Job Description

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