Assistant QA Manager

Key Responsibilities:

• Assist in managing QA activities across production, packaging, and documentation.
• Support internal audits, regulatory inspections, and CAPA implementation.
• Review and approve batch records, change controls, and SOPs.
• Coordinate with cross-functional teams to ensure compliance with quality standards.
• Train and guide QA staff on quality practices and GMP requirements.
• To monitor compliance of GMP and GLP requirements.
• To active participate and compliance of the client, regulatory audit and self-inspection.
• To handle and maintain the QMS Documents, such as Change control, Incident, Deviation, CAPA, OOS, Recall, Cleaning validation and Market complaints. Maintain annual trends of it.
• To give training to new employees, preparation of Job responsibility and also give schedule training.
• To prepare and revise the SOPs and relevant formats as and when require.
• To prepare, update and execute Site master file, Validation master plan, Quality manual.
• To monitoring of Stability chamber and BOD Chambers.
• To release batch and approve any document in the absence of Head QA/ Asst. Manager.
• To review APQR (Annual product quality review).
• To review PV /Hold time /BMR /BPR /Specification /MOA / Stability protocol / Stability schedule.
• To review technology transfer documents.
• To check and approve artwork of carton, outer carton, foil, leaflet, Shipper etc.
• To do require entries in ERP System, such as add and verify master formula of RM/ PM, addition of generic master, RM/ PM/ Other material master, upload artwork in ERP.
• To monitor document control room.
• To review batch numbers for products.
• To monitor pest control activity.
• To monitor review & handle retrieval of BMR/ BPR and Batch Close.
• To review and release Microbial limit test reports.
• To review Batch creation, Procurement planning in ERP.
• To review inspection and destruction of control samples as per SOP
• To issue, retrieve, distribute, master, obsolete, storage and handling of documents of all departments.
• To prepare, review qualification documents & take part during qualification.
• To check party sample and send to parties as and when required.
• To verify 2D & shipper label.
• In process checks at granulation, compression, coating stage.
• To check and give line clearance at each stage like dispensing, granulation, blending, compression, coating, capsule filling etc.
• Sampling and send to QC with entry in ERP system and sample testing intimation slip.
• Sampling of in process sample, process validation, hold time, stability sample, control sample, cleaning validation and Swab/rinse samples.
• To check and monitor on line documents like environmental monitoring records, BMR/BPR, usage logs of equipment/change part/ accessories and other logbooks.
• To perform Acceptable Quality level (AQL) of each stage like compression, coating inspection & packing.
• To Review of BMR stage wise and batch release for the next stage.
• Status label checking for area, system, product container, change part, materials, machines etc.
• Handling and Monitoring of rejection at each stage.
• Handling and Calibration of IPQC instruments.
• Monitoring and checking of cleaning of manufacturing area, drain, janitor and wash rooms.
• To check & record cleaning & environmental monitoring records of IPQA area.
• To check and monitor primary packing line and to perform in process test.
• In process check and line clearance for primary and secondary packing.

Job Types: Full-time, Permanent

Pay: ₹35,000.00 - ₹45,000.00 per month

Benefits:

• Cell phone reimbursement
• Commuter assistance
• Flexible schedule
• Health insurance
• Internet reimbursement
• Paid sick time
• Paid time off
• Provident Fund

Schedule:

• Day shift

Supplemental Pay:

• Performance bonus

Work Location: In person