In this post Quality Assurance Pharmacist Job Description in Pharamceuticals Industriaies is given. All responsibilies and tasks are performed by Quality Assurance Manager.
- Annual Product Quality Review
- Approve or reject drug products manufactured, process ed, packed, or held under contract by another company, i.e., final product release is not delegated to a contractor
- Assisting other departments in day to day activities to ensure overall smooth production
- Audit contract packaging sites to monitor and assure adherence to pharmaceutical quality system requirements.
- Be independent review er and approver with respect to manufacturing and process/product development units
- Check in process control.
- Complete documentation required for regulatory agencies (SOP, SMP, Dossiers).
- Completion of log books and BMRs.
- Conducting periodic washing of Reverse Osmosis Plant to ensure availability of purified water for QC testing and Production processes
- Conductional training programs for continual improvement of personnel.
- Control and Reprocessing of non- conforming products.
- Controls production process and production facilities .
- Coordinate with the global GxP experts for their input in all GxP related matters.
- Co-ordinate with the manufactured department in controlling their process and products at every stage of manufactured to meet the established specifications through testing, auditing and reporting.
- Daily Calibration of weighing balances
- Daily Sanitization Checklist
- Daily temperature and humidity checks of different areas such as warehouse, production areas, quality control lab and finished goods store
- Dealing all audits.
- Dispensing of Raw and Packaging Materials.
- Effective implementation of All SOPs on site.
- Ensure facility compliance with cGMP and FDA regulations, best practices, and standards of quality.
- Ensure in-process controls are performed during manufacturing operations and results are satisfactory
- Ensure investigation is conducted and root cause is eliminated for production and control record errors , discrepancies , and failure to meet specification, including quality attributes
- Ensure that procedures and specifications are appropriate and followed Ensure that appropriate manufacturing in-process controls are implemented
- Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities
- Ensures conformance of manufacturing process es with organizational objectives and policies with the coordination of Production Executive/ Asstt. Manager Production.
- Ensures that all production equipment’s are maintained in good working order.
- Ensures the general cleanliness and hygienic conditions of the manufacturing areas.
- Experience in Validation of manufacturing processes.
- Finding regulatory answers to queries asked by European clients and Contract manufacturing organization (CDMO and CMOs).
- Giving Line Clearances for different production processes such as dispensing, powder mixing and filling and packing operations
- Handling of deviations.
- Handling of market Complaints, product recall and Change Control Systems.
- Handling The Documentation at Site related To Record Maintenance Of all GMP Documents Including SOPs, Protocols, Reports, STMs, BMRs and BPRs.
- In-process samples taking and checks
- Insure the organizational compliance to the relevant cGMPs.
- Internal Quality Audits.
- Involved in planning, Monitoring of different manufacturing process , workers and their training.
- Issuance, Retrieval & Tracking Of all Master Documents Records.
- Keep current with good industry practices , and applicable Audit for compliance to policies and procedures : on paper vs. practice
- Line clearance in different sections
- Line related to all operations on site like Dispensing, Manufacturing, and Filling & Packing Operations
- Maintaining and reviewing of Batch Manufacturing Records and Standard Operating Procedures related to various products applicable to the facility.
- Maintaining Annual departmental Training Records, TNAs.
- Maintaining Issuance, Retrieval of All Logbooks on site.
- Maintenance of Quality Control records of manufacturing procedures for each batch manufactured.
- Makes sure the on job training of production personnel.
- Manufacturing process and in process quality assurance in Tablet, Syrup, Capsule and all other section overprinting.
- Mock Audit participation as scriber.
- Monitors drugs manufacturing activities in compliance with the requirements of cGMP.
- Observer in inspections, in particular, by SRA inspections.
- Overall technical and administrative management of QA functions effectively & efficiently.
- Plan and manage all the activities of the Quality assurance to assure the quality of all products manufactured by the company.
- Played key role for Site readiness for Inspections
- Preparation and review of labelling and other packaging material content
- Preparation and review of product dossiers of sachet and tablets for Regulatory agencies products enlistment
- Preparation and review of Standard Operating Procedures (SOPs) for different Warehouse and Production areas
- Preparation of S and P parts of the dossier.
- Preparations and Review QA controlled documentation (SOP’s, batch records, working instructions).
- Preparations of SOP’s, batch records, Working instructions, deviations,
- Preparing PQRs (product quality Review) .
- Process monitoring and Process control.
- Production Record and documentation Review.
- Raise deviation and fulfill it.
- Receiving of raw materials and packaging materials according to standard operating procedures
- Records of release, quarantine or rejection of components and finished products, containers, closures and labels based on Quality Control test results.
- Responsible for complying GMP.
- Responsible for Self Inspection & Internal audit plans.
- Review and approve/reject any document that gives work instructions and set requirements such as procedures , protocols , test methods , and specifications — including changes to these documents
- Review and approve/reject production batch records and make the final decision to release a product lot into commerce.
- Review and final release/approval of BMRs.
- Review and preparation of batch release documentation.
- Review and validate labeling and distribution documentation. Manage equipment calibration, qualification, and maintenance program.
- Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to concern manager Report on product, process and system risks and keep management informed
- Review of paper and electronic batch records on completeness, clarity and GMP compliance.
- Review of production batch record.
- Review of raw material related to documentation and release of raw Materials.
- Reviewing and approving new formulations, labels, shelf life extensions, repacks and in-house preparations.
- Sampling of Raw materials and check there related documents.
- Supervising and conducting dispensing of raw materials for Production
- Supervising mixing processes of Sachet and Tablet sections
- Taking samples of raw materials and packaging materials for QC testing
- Trouble shooting
- Working in Tablet, capsule, syrup, dry And liquid injection, Ceph, Area, sachet and all other sections.
- Write review, and approve Incidents ,deviations, RCA, corrective and preventive actions, change controls, specifications, standard operating procedures, test methods, stability and process protocols, and test results.
- Writing, reviewing and approving Quality documentation, including validation protocols and reports, change controls, Annual Product Quality Review and Good Manufacturing Practice (GMP) deviations.
- Writing, reviewing and approving Standard Operating Procedures (SOPs).