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An action plan in response to an excursion in an aseptic filling area is crucial for maintaining product integrity and ensuring compliance with regulatory standards. Here's a detailed action plan: 1. Immediate Response Stop the Aseptic Operation: Immediately halt the filling operation to prevent any potential contamination from spreading. Containment: Identify and contain the affected area or equipment to prevent further exposure or contamination. Segregation: Segregate any in-process materials, products, and components that may have been exposed to the excursion. 2. Notification Notify Key Personnel: Inform the relevant departments, including Quality Assurance (QA), Production, and Microbiology, of the excursion. This may include notifying senior management if necessary. Regulatory Reporting: If the excursion is deemed critical, assess the need for notifying regulatory bodies according to local and international guidelines. 3. Investigation Root Cause Analysis (RCA): Conduct a thorough investigation to identify the root cause of the excursion. Use tools like Fishbone Diagram, 5 Whys, or Fault Tree Analysis to ensure a comprehensive investigation. Environmental Monitoring: Perform environmental monitoring (e.g., air, surface) in the affected area to assess the extent of contamination. Review Historical Data: Review historical environmental data, equipment logs, and personnel records to identify any trends or deviations that could have contributed to the excursion. 4. Corrective Actions Immediate Corrections: Implement immediate corrective actions to rectify the identified cause, such as equipment repair, retraining of personnel, or adjusting procedures. Cleanroom Decontamination: Perform a thorough cleaning and disinfection of the affected area, following standard operating procedures (SOPs). Equipment Calibration/Validation: Revalidate any equipment involved in the excursion to ensure it is functioning within acceptable limits. Personnel Retraining: If human error is identified as a root cause, ensure that personnel are retrained on proper aseptic techniques. 5. Preventive Actions Review and Revise SOPs. Strengthen Monitoring. Continuous Training. 6. Documentation Deviation Report: Document the excursion as a deviation, detailing the findings of the investigation, corrective actions, and preventive actions taken. 7. Revalidation and Restart Environmental Requalification: Perform requalification of the cleanroom environment and equipment to ensure they meet the required standards. Aseptic Process Simulation (APS): Conduct an APS (media fill) to validate the aseptic process before resuming operations. 8. Post-Event Monitoring Enhanced Surveillance: Implement heightened environmental and process monitoring following the incident to ensure no recurrence. Trend Analysis: Continuously analyze monitoring data for trends that could indicate a recurrence of the issue.

Key Responsibilities 1 Manage day-to-day production operations to meet company objectives, ensuring adherence to production schedules and quality standards. 2 Coordinate production planning and resource allocation to optimize efficiency and minimize downtime. 3 Monitor production metrics and implement corrective actions to resolve bottlenecks and improve productivity. 4 Ensure strict compliance with cGMP norms and regulatory requirements in all production activities. 5 Support regulatory audits and inspections, implementing corrective and preventive actions as needed. 6 Assist in the development and enforcement of standard operating procedures (SOPs) for production processes. 7 Lead and mentor the production team, establishing a culture of continuous improvement and accountability. 8 Conduct performance evaluations, provide feedback, and facilitate training to enhance team capabilities. 9 Collaborate with cross-functional teams (QC, QA, Engineering) to optimize production workflows and resolve technical issues. 10 Monitor and manage production budgets, including material procurement and consumption. 11 Ensure adherence to budgetary constraints while maximizing operational efficiency and minimizing waste. 12 Implement production plans to achieve quantitative and qualitative targets, driving operational excellence. 13 Maintain a safe working environment and ensure compliance with environmental and safety regulations. 14 Monitor pollution control measures and hazardous waste management to meet regulatory standards. 15 Lead initiatives for process optimization, including validation studies and equipment calibration. 16 Investigate and address production deviations, market complaints, and product recalls through thorough root cause analysis and CAPA implementation. 17 Evaluate proposed changes in product specifications or manufacturing processes, ensuring compliance with quality standards and regulatory requirements. Product range: Herbal extracts, Botanical extracts, Phytochemicals, Oleoresin #Hiring #JobOpening #JoinOurTeam #CareerOpportunity #ProductionManager #NowHiring #ApplyNow #JobAlert #WorkWithUs #TeamExpansion #JobSearch #CareerGrowth #Employment #JobVacancy #HiringNow #JobOpportunities #ProductionJobs #SeniorManager #WorkplaceCulture #JobListing#SeniorManagerProduction #ProductionManagement #ManufacturingLeadership #OperationsManagement #ProductionExcellence #CareerOpportunity #NowHiring #JoinOurTeam #Leadership #ManufacturingJobs #ProductionJobs #JobOpening #TalentAcquisition #HiringNow #JobSearch #CareerGrowth #OperationsLeader #JobVacancy #TeamExpansion #WorkWithUs

Cleanroom testing Once a room has been assigned a classification, certain environmental parameters (physical and microbiological) are to be met on a routine basis. For viable monitoring it is normal for the microbiologist to set action levels (and warning levels, which are equivalent to what are sometimes referred to as alert levels) based on an historical analysis of data. The frequency of the assessment of other parameters (as described below) should be assessed based on a risk management approach. This approach should consider the room use and the risk to the product. Factors to consider may include ; 👉room activities, 👉exposure risk, 👉room temperature 👉Process stage. 👉Duration of process activities. 👉Water exposure. The emphasis should always be upon environmental control rather than simply environmental monitoring. That is, where a risk is identified, the risk should be minimized as part of a strategy of bringing the clean area into tighter control. Where a risk cannot be minimized but continues to exist then carefully targeted monitoring should be undertaken and the data reviewed and examined for trends, by apharmaceutical microbiologist. Cleanroom qualification frequencies

Urgent opening for a leadership role in Drug Product Engineering at Malaysia location in one of the leading Pharma company. Role: Drug Product - Engineering Experience: 18+ years Job Description: - To carry out planned preventive maintenance on all plant and equipment aiming to achieve maximum plant availability with a target of zero unplanned downtime. - To raise communication memo for Preventive Maintenance. - To maintain availability of spare part of all equipment at all time and ensure no downtime due to non-availability spare part. - To respond, carry out and record equipment maintenance activity effectively and efficiently. - Observation and rectification of equipment/ machines condition and detection of unusual conditions ina proactive manner. - Daily reporting of activities and updating any issues at work to the superior. - Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ. - To attend, record and conduct all trainings required as per training matrix/ schedule. - Generate various document procedure/protocol/report as and when required. - Fill log sheets/ checklist/ history card/ planner as described in the SOPs. - Follow the established procedures and policies of the company. - Participate in project activity on process optimisation, facility upgrade, or objective. - To propose objectives and targets on work area and comply to set timeline. - Participate in cost and energy management program. - To provide feedback and ensure all the audit findings are closed within the stipulated time. - On routine basis to provide improvement proposal on equipment, process, or quality system. - To authorize the invoice, bills and vouchers for the goods received. - Responsible for data management, trending and periodic presentation. - To prepare shift scheduling. - Evaluate the personnel who have undergone training. - Issue of work permits and gate pass. - To plan/ prepare /review/ approve the preventive maintenance activity/ schedule. - To evaluate and approve on vendor performance/ quality/ capability — vendor evaluation/ management process. - To prepare and achieve team budgets and plan/ performance objectives. - Takes a leadership role in department/ organizations. - Approval of specific equipment for use. - Cost management in budgeting and expenses. - To interview/ managing contract, sub contract works and workers. - Leave and claim approval. - To prepare and plan the material management. - Decision making on priorities. #drugproductengineering #preventivemaintenance #engineering #projects #injectables #formulation #biologics #biotech Interested candidates can share resume on [email protected]

Mitigating Product Quality Risks in Aging Facilities l  l  1. Regular Audits & Inspections: - Conduct routine internal audits and third-party inspections to assess facility conditions and identify areas of risk, ensuring that preventive maintenance is in place. 2. Upgrading Infrastructure and Equipment: - Gradually upgrade or replace outdated equipment, control systems, and facility components to align with modern standards and improve product quality consistency. 3. Improved Maintenance Programs: - Implement robust predictive maintenance programs to prevent equipment failures and ensure consistent performance through better monitoring, regular calibration, and timely repairs. 4. Environmental Monitoring: - Continuously monitor and control environmental conditions (e.g., HVAC systems, cleanroom controls) to prevent contamination and maintain compliance with cGMP. 5. Training & SOP Revisions: - Regularly update SOPs & ensure that personnel are trained to follow the latest compliance guidelines, focusing on preventing human error and improving process efficiency. 6. Invest in Modern Technologies: - Where possible, invest in automation, data integrity solutions, and continuous manufacturing technologies that reduce manual interventions and improve consistency. Aging pharmaceutical facilities present significant risks to product quality, including equipment failures, contamination, and non-compliance with modern standards. Proactively addressing these risks through audits, upgrades, maintenance, and modern technology adoption is critical to ensuring product safety, maintaining regulatory compliance, and protecting public health. #ProductQualityRisk #Compliance #Contamination

Urgent opening for a leadership role in Drug Product Engineering at Malaysia location in one of the leading Pharma company. Role: Drug Product - Engineering Experience: 18+ years Job Description: - To carry out planned preventive maintenance on all plant and equipment aiming to achieve maximum plant availability with a target of zero unplanned downtime. - To raise communication memo for Preventive Maintenance. - To maintain availability of spare part of all equipment at all time and ensure no downtime due to non-availability spare part. - To respond, carry out and record equipment maintenance activity effectively and efficiently. - Observation and rectification of equipment/ machines condition and detection of unusual conditions in a proactive manner. - Daily reporting of activities and updating any issues at work to the superior. - Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ. - To attend, record and conduct all trainings required as per training matrix/ schedule. - Generate various document procedure/protocol/report as and when required. - Fill log sheets/ checklist/ history card/ planner as described in the SOPs. - Follow the established procedures and policies of the company. - Participate in project activity on process optimisation, facility upgrade, or objective. - To propose objectives and targets on work area and comply to set timeline. - Participate in cost and energy management program. - To provide feedback and ensure all the audit findings are closed within the stipulated time. - On routine basis to provide improvement proposal on equipment, process, or quality system. - To authorize the invoice, bills and vouchers for the goods received. - Responsible for data management, trending and periodic presentation. - To prepare shift scheduling. - Evaluate the personnel who have undergone training. - Issue of work permits and gate pass. - To plan/ prepare /review/ approve the preventive maintenance activity/schedule. - To evaluate and approve on vendor performance/ quality/ capability – vendor evaluation/ management process. - To prepare and achieve team budgets and plan/ performance objectives. - Takes a leadership role in department/ organizations. - Approval of specific equipment for use. - Cost management in budgeting and expenses. - To interview/ managing contract, sub contract works and workers. - Leave and claim approval. - To prepare and plan the material management. - Decision making on priorities. #drugproductengineering #preventivemaintenance #engineering #projects #injectables #formulation #biologics #biotech Interested candidates can share resume on [email protected]

Urgent opening for a leadership role in Drug Product Engineering at Malaysia location in one of the leading Pharma company. Role: Drug Product - Engineering Experience: 14+ years Job Description: - To carry out planned preventive maintenance on all plant and equipment aiming to achieve maximum plant availability with a target of zero unplanned downtime. - To raise communication memo for Preventive Maintenance. - To maintain availability of spare part of all equipment at all time and ensure no downtime due to non-availability spare part. - To respond, carry out and record equipment maintenance activity effectively and efficiently. - Observation and rectification of equipment/ machines condition and detection of unusual conditions in a proactive manner. - Daily reporting of activities and updating any issues at work to the superior. - Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ. - To attend, record and conduct all trainings required as per training matrix/ schedule. - Generate various document procedure/protocol/report as and when required. - Fill log sheets/ checklist/ history card/ planner as described in the SOPs. - Follow the established procedures and policies of the company. - Participate in project activity on process optimisation, facility upgrade, or objective. - To propose objectives and targets on work area and comply to set timeline. - Participate in cost and energy management program. - To provide feedback and ensure all the audit findings are closed within the stipulated time. - On routine basis to provide improvement proposal on equipment, process, or quality system. - To authorize the invoice, bills and vouchers for the goods received. - Responsible for data management, trending and periodic presentation. - To prepare shift scheduling. - Evaluate the personnel who have undergone training. - Issue of work permits and gate pass. - To plan/ prepare /review/ approve the preventive maintenance activity/schedule. - To evaluate and approve on vendor performance/ quality/ capability – vendor evaluation/ management process. - To prepare and achieve team budgets and plan/ performance objectives. - Takes a leadership role in department/ organizations. - Approval of specific equipment for use. - Cost management in budgeting and expenses. - To interview/ managing contract, sub contract works and workers. - Leave and claim approval. - To prepare and plan the material management. - Decision making on priorities. #DrugProductEngineering #PreventiveMaintenance #engineering #projects #injectables #formulation #biologics #biotech #parenteral #sterile #PFS Interested candidates can share resume on [email protected]

Check out this job at Solenis. Comment "Interested" for more details About the job As Associate regulatory specialist handle key regulatory activities like compliance workflows, creation of SDS, labels, product registrations, notifications, renewals as required to ensure regulatory compliance for Diversey products, The person will be reporting to the Manager Regulatory Affairs. As a Regulatory Expert Author Safety Data Sheets for multiple geographies across the globe as per applicable hazard communication regulations. Derive hazard classifications for substances and mixtures using various classification regulations including but not limited to GHS, CLP, & OSHA Hazard Communication Standard. Perform raw material compliance, formula and finished products reviews for various regions as per the Globally Harmonized System (GHS). Maintain data integrity within the SDS authoring software & ERP System to ensure that Safety Data Sheets & information reflect the most current health, safety, environmental, and regulatory information available. Efficiently address queries from internal/external stakeholders & coordinate with team lead/ SME’s if required, for quick resolution for high priority requests. Prioritize & complete requests based on defined turnaround time. Ensure records are maintained as per defined formats. Good knowledge of global chemical regulatory environment and applicable legislations/guidelines Working experience in a corporate regulatory environment with a proven track record of interaction with competent authorities in carrying out the responsibilities of product registration, regulatory compliance, regulatory consulting or equivalent Knowledge of hazard communication as per GHS and country specific requirements, hands-on experience on label and SDS authoring Demonstrated success in completion of difficult tasks in a timely manner Good communication, presentation, and analytical skills. Desirable to have knowledge of regulatory terminology and regulatory landscape. Ability to work effectively with a cross functional team and independently with minimal supervision Excellent communication in English, verbal and writing. #RegulatorySpecialist #ChemicalCompliance #RegulatoryAffairs #SafetyDataSheets #GHSCompliance #ProductRegistration #HazardCommunication #RegulatoryCompliance #CLP #OSHACompliance #SDSAuthoring #GlobalRegulations #ComplianceWorkflows #RegulatoryConsulting #CrossFunctionalTeam #RegulatoryExpert #CorporateCompliance #DiverseyCareers #RegulatorySkills #RegulatoryKnowledge #ChemicalSafety