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IPQV (Morocco Plant)
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- To carry out line clearance for batch manufacturing and batch packing.
- To carry out in-process tests for batch manufacturing and batch packing.
- Verification of API Calculations in Raw Material stores.
- Review yield of each process stage and compare with standard.
- Ensure basic norms of cGMP, cGLP and safety are being followed.
- Ensure proper cleanliness and maintenance of department premises and equipment.
- Ensure on-line, timely, legible and correct entries of all operations activates.
- Participating in reviewing, creating and monitoring quality systems, procedures, specifications and amendments. Suggesting for Improvement, review and upgrading of existing SOPs, specifications, test methods and work systems.
- Ensure availability of current SOPs at shop floor and conformance of activities with the current SOPs.
- Ensure status labelling in the area.
- Ensure calibration and preventive maintenance of manufacturing, packing equipment and laboratory Instruments is done as per schedule.
- Ensure proper storage of materials in stores.
- Ensure that all validations and Qualifications are properly planned, conducted and documented.
- To qualify new, modified areas, equipment and ensure their re-qualification.
- Review logbooks.
- Participation in investigation of any non-conformance observed at the shop floor.
- To perform activities in software like SAP, etc based on the roles & rights provided in the system.
- Issuance and review of executed batch manufacturing records and batch packing records.
- Issuance, approval and issuance of batch documents from SAP system whenever required.
- Issuance of logs to user department whenever required.
- QA observation rounds in all areas.
- Scheduling of visual Inspectors Qualification.
- Handling of data logger and review of report.
- Checkweigher rejection checking.
- Critically examining the environment with a view to minimizing product contamination. Monitoring and control of manufacturing environments.
- Ensure strict adherence to environment, health and safety.
- To identify areas of wastage and areas of work simplification.
- Imparting training with respect to GMP, Safety, Hygiene, application and principles of Quality Assurance. To ensure that the required initial and continuous training of department personnel are carried out as per the need.
- Compliance of Audit observations.
- To evaluate and approve / reject of any Reworking of products.
- Evaluate complaints related to product quality received from any source.
- Participate in investigation of recalled / returned products / complaints.
- Designation / Monitoring of storage condition for materials and products.
- Retention and destruction of documents and records as per SOP.
- Control on batch release system i.e. assembling and review all documentation related to the processing, packaging and testing of each batch of the product before authorizing for sale. Control and release / rejection of pharmaceutical products.
- Certification of COAs.
- To operate Instrument calibration management system based on the roles and rights provided in the application.
- Execution / participation in all validation and qualification activities. To assure that all validations are properly planned, executed and documented. Carry out validation and optimization studies.
- Review and generation of Master BMR and master BPR.
- Generation, approval and issuance of batch documents, validation protocols and reports, written procedures including amendments and control of soft and hard copies. Evaluation of batch record.
- Issuance and review of Batch packing record and Batch Manufacturing records as and when required.
- Control on batch release system i.e. assembling and review all documentation related to the processing, packaging and testing of each batch of the product before authorizing for sale. Control and release / rejection of pharmaceutical products.
- Interacting and coordinating with regulatory affairs to obtain approval for manufacturing assessment batches, feasibility batches and for obtaining approval for destruction of expired / discontinued batches.
- Review, evaluation and approval / rejection, implementation of change requests related to systems, facility, Equipment, instruments, product and document.
- Ensure line clearance, overprinting proof checking and other controls related to batch manufacturing and batch packing. Performing in-process checks. Improve in-process checks.
- Conducting unit operations. Improvement, continuous review and updating of existing SOP’s, specifications, test methods, work systems including risk assessment with respect to the current guidelines.
- Responsible to maintain all necessary controls on starting materials, intermediate products and other in process controls, and calibrations that are carried out.
- Ensure that all pest control activities are carried out as per schedule.
- Co-ordinating for conducting transporter validation.
- To perform risk assessment wherever required.
- Periodic review of all quality function and procedure for appropriateness and validity.
- Ensure that pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of Marketing Authorization and any other regulations relevant to the production.
- Monitoring of the IPQC of dosage form, process control, online documentation. Deviation if any bring it to the notice of the head of department.
- Co-ordinating for online QA/Lab QA observations, self-inspection observations and compliances.
- Ensure that products are manufactured and tested in a way that takes in to account the requirements of cGMP and cGLP, requirement of product registration to autorities.
- Monitoring shop floor production activity and ensure compliance to established standards and review shop floor records, logbook for compliance.
- Preparation / updation /approval of various schedule and lists in the department.
- Ensure investigation of out of specification / out of trend, process and procedure deviation are appropriately performed and documented. Ensure appropriate corrective and preventive actions based on the results of the investigations are identified and implemented.
- Review and approve the annual product quality report of all drug products and its relevant data / records / trends to assure that products are meeting consistently quality standards. And recommend for improvements in product quality as applicable.
- Review of Qualification documents, protocols, report, sampling, instruction, test method and other quality control procedure. Review of BMS summary reports and trends.
- Review of stability test report.
- Updating organization chart and job responsibilities in the department etc.
- Conduct or arrange staff awareness and motivation programs.
- Any other assignment allocated by QA Manager.
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