QA Officer

2 days ago

Sachin Surat Gujarat, India TNS PHARMA PVT LTD Full time

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: ₹20,000.00 - ₹25,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift
- Morning shift

**Education**:

- Bachelor's (required)

**Experience**:

- total work: 2 years (preferred)

**Location**:

- Sachin, Surat, Gujarat (preferred)

Work Location: In person

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