- 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.
- To support preparations at site for external audits. Help in preparation of compliance reports.
- To review the change control proposed and to ensure closure of the change controls, post implementation after conducting impact assessment.
- To prepare monthly report and furnished required information to QA Head /Designee.
- To coordinate and conduct internal audits of GMP compliance.
- Allocate the responsibility to the IPQA team for the shift operations if applicable.
- To conduct training for IPQA personnel.
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- To prepare answers to the queries received from Regulatory agencies on the submissions and RA send the draft for review to QA. On confirmation prepare the final version and send it to Regulatory Affairs department, for onward submission to respective Regulatory agencies.
- To prepare & review the license application to FDA for additional products, COPP, FSC and other FDA related documents before submission.
- In the absence of QA head/Designee, the responsibility shall be delegated upward to QA Asst. Manager/Designee.
- QA Executive/Designee:
- To develop efficient filling system of all QA documents by assigning file numbering system, prepare master index, lists of documents and ensure correct filing of documents.
- To maintain, destruction records and ensure safe destruction of obsolete records.
- Preparation of SOP’s.
- Preparation & review of master formulae Record.
- Preparation & Review of batch manufacturing record and batch packing record.
- Review of scale up (Optimization) activity reports.
- Assist in execution of validation and qualification activities.
- Customer complaint investigation.
- Review of filled BMR/BPR.
- Logging of CAPA, MC, OOT, OOS, Deviation/Incident, Change control & other documents.
- Review & compliance of cleanliness and environmental conditions in manufacturing area prior to and during manufacturing.
- Monitoring of destruction/disposal and reprocessing activities; if any.
- To Prepare & review of Annual Product Quality Review.
- To monitor IPQA activities on shop floor randomly.
- To coordinate for annual training of personnel in the Site.
- Ensure the maintenance of control sample and stability sample.
- Responsible for issuance, retrieval, retention and destruction of documents such as Batch Manufacturing Record and Batch Packaging Record, SOP, formats, logbooks, analytical worksheets, specification, Standard testing procedure, General testing procedure, material bin card.
- QA Officer/ Sr. Officer:
- To check of cleanliness and environmental conditions in manufacturing area prior to and during manufacturing.
- To maintain the inward/outward records in the documentation cell.
- Collection of data for annual product quality review.
- To carryout Line clearance checks.
- To carryout In-process checks in Warehouse, manufacturing & Packing departments.
- To check on line documentation.
- To check SOP compliance on shop floor.
- Sampling of semi-finished and finished product.
- Swab and rinse water sampling.
- Control sample & Stability sample collection, storage and monitoring.
- Checking of instrument log books, calibration record & other document in production, QC, Engineering & Warehouse.
Job Type: Full-time
Pay: ₹15,000.00 - ₹22,000.00 per month
Benefits:
- Health insurance
- Paid sick time
- Provident Fund
Education:
Work Location: In person
