- Responsible for overall quality of products and compliance of GMP at the site.
- Line clearance prior to dispensing, manufacturing, packing and validation activity.
- Sampling during manufacturing of validation, exhibit and commercial batches.
- In process control, routine inspection and online process verification and documentation.
- Preparation, review and approval of documents such as SOP, BMR, BPR, SMF, VMP, APQR, MFR validation protocols/report and qualification protocols/report.
- Execution and evaluation of qualification and validation studies.
- To evaluate and authorize rework or reprocessing of the batch.
- To review batch documentation and release the batches for distribution.
- To involve in quality control functions to ensure GLP and data authenticity.
- Review and approval of work sheet, COA, raw and packing material specification, semi- finished specification, finished product specification and stability protocol.
- To review stability data generated at site and submit to RA for dossier preparation.
- To control, distribute, retrieve and destruction of the master and executed documents such as BMR, BPR, analytical work books, master SOPs, protocols, reports, log books.
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- Verification of calibration, cleaning of instruments and manufacturing equipments.
- Participation in technology transfer process from F & D and other manufacturing site.
- To ensure implementation of quality manual/quality policy, guidance documents and directives.
- To monitor changes in the official monographs and ensuring its implementation at sites.
- To conduct the internal audit, lead the site for external audits and their compliance.
- To ensure personnel training and its evaluation at site.
- Vendor qualification.
- Approval of technical agreements.
- To ensure issuance, control and retrieval of art work and shade card.
- Responsible for risk assessment studies.
- Responsible for investigation and closing of OOS, OOT, deviation, incident, change control and market complaints.
- Responsible for preparation & review the license application to FDA for additional products, COPP, FSC and other FDA related documents before submission.
- To ensure the accuracy, integrity, legibility and availability of documents. Instruction documents should be free from errors and available in writing.
- Any activity covered by the GMP guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid any misunderstanding which could result in a product or operation of unsatisfactory quality.
- QA Head/Designee:
- Responsible for overall quality of products and compliance of GMP at the site.
- To coordinate with Production, HR, Engineering, QC and Warehouse departments.
- Shall be the approving authority for all the master documents such as BMR, BPR SOPs, qualification documents of analytical and manufacturing equipments, specifications, COA, validation protocols, Market complaints, deviation/Incidents, change control, CAPA, OOS and OOT results.
- Release the batches for distribution.
- Coordination with cross functional team, RA, F & D for Review & approval of analytical technology transfer and method validation documents.
- To evaluate and authorize rework or reprocessing of the batch.
- Responsible for approval of technical agreements.
- Responsible for approval of Site Master File,VMP,QM, SOPs, SM, TM & other documents.
- Responsible for approval & investigation of the market complaint and prepare response and forward it for further review.
- To approve the CAPA and comment on the same. Ensure implementation of CAPA.
- To decide, monitor & ensure the batch recall.
- Coordination with Regulatory Affairs for preparation and filling of dossiers.
- To liaison with local FDA for inclusion/grant of license and certifications.
- To lead the site for internal, external GMP audits and their compliance.
- To approve the qualification, validation and revalidation activities and their compliance at the site as per validation master plan.
- To ensure personnel training and its evaluation at site.
- To ensure the shop floor activities and ensure day to day compliance.
- To interact with F & D, Purchase, RA for artwork, vendor qualification and other non conformance issues related to products manufactured at the site.
- To coordinate with HR for recruitment of QA personnel and their induction training.
- To control the budget expenditure.
- Approval of self-audit action plan.
- Approval of destruction/disposal.
- Collecting information and providing Guidelines for personnel knowledge update through information sharing and /or trainings. Advising on training requirements, conducting training on Quality Manual /Quality Policy and monitoring the training activity in the company. Support preparation of training modules and circulating the same to sites.
- Suggesting improvements in product presentation/ packing /quality.
- To monitor changes in the official monographs, guidelines and ensuring its implementation at sites.
- Evaluation & approval of risk assessment in the site.
- To ensure the compliance with validation master plan and requalification of utility, equipments, procedures and systems as per the frequency described.
- To ensure the protocols, related qualification, validation documents and their summary report and related formats of engineering, manufacturing and testing instruments.
- To conduct vendor audits.
- Appraise customer’s requirements and make sure they are satisfied.
- QA Asst. Manager/Designee:
- Preparation of Site Master File, VMP, QM, SM, TM & other documents.
- Monitoring and review of annual product quality review.
- To involve in quality control functions and ensure GLP and data authenticity.
- To ensure issuance, control and retrieval of Art work and shade card.
- To review the executed worksheets / specifications of raw material, packing material, semi-finished and finished product.
- To review the batch documents and QC data and give clearance for release for finished products.
- Review of stability protocols and stability data with coordination of QC and inform to QA head/Designee about the outcome of the stability data and submit to RA for dossier submission purpose.
- Review of calibration records of analytical instruments.
- To monitor changes in the official monographs and inform to QA Head/Designee.
- To review the SOPs and its implementation.
- To ensure the in process testing and compliance during operations.
- To evaluate and approve extra material/ excess return request made by production.
- To assist in investigation of the deviations/ incident, non conformances, market complaint, OOS and OOT.
Job Type: Permanent
Pay: ₹15,954.86 - ₹25,022.19 per month
Benefits:
- Health insurance
- Paid sick time
- Paid time off
Work Location: In person
