Quality Assurance Pharmacist Job Description in Pharmaceuticals

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).