Urgent Opening For QA -QMS at Stallion Laboratories Pvt Ltd

Roles and Responsibilities

Document Issuance, QMS and Document cell: -

• Issuance and Retrieval of GMP documents of QA and cross functional department.
• Issuance of BMR, BPR as per document procedure i.e. manual or SAP. Issuance and Retrieval of logbooks, loose formats, protocols, drawing, Specifications and other GMP documents.
• Distribution of site, CQ and other cross functional department SOPs and ensures their implementation and training.
• SOP, Protocols, Specifications, TDS, BMR, BPR and other GMP documents effective, master and obsolete as per documentation procedure.
• To ensure document retention and destruction as per SOP.
• Handling of Archival room.
• Handling of Errata rectification.
• o prepare and review of sop, protocol, APAX document and other GMP document.
• Handling of Stamp management like issuance, retrieval and destruction activity.

• Technical Training Cell:
  • Handling of Emtims Software i.e. Site training coordinator (STC). • To manage all Technical training activities which include execution, coordination & implementation of all training activities. • To planning scheduling, conducting orientation training for new joiner & existing company employee/ contract worker. • To ensure 100% completion of training against all SOPs (revision & implementation of new SOP), training calendar and training matrix. • To visit the shop floor and verified the GMP Training compliance as well support the DTC for training done at shop floor. • Maintaining Job description as per respective activities and training record as per assigned job. • QMS and Lab QA: • Handling and co-ordination of change control / CAPA and completion of action items within timeline and effectiveness evaluation. • Handling of Trackwise software for QMS activity i.e. Change control, CAPA and Lab event.
• Co-ordination for Quality review meeting and handling of actions identified from outcome.
• Co-Ordination for self-inspection activity, Audit planning, Audit report, compliance and CAPA.
• Review of day to day and online compliance. Ensure compliance of GMP in shop floor.
• Review of raw material, Packaging material, stability data, Specifications, MOA, TDS, etc.
• To Review of analytical raw data and electronic data generated in quality control lab.
• Monthly audit trail review for QC instruments like HPLC (Empower), UV (Lab solution), Stability chambers (Daas), etc.
• Review and monitoring of instrument calibration, qualification and CSV activity.
• Responsible for Usage decision (UD) for RM, PM, Misc. material in SAP system.
  
• Collaborate with cross-functional teams to resolve issues related to BMR/BPR review.
  
• Provide training on QMS procedures to team members.
  
• Conduct regular audits to maintain quality standards (GMP).
  
• Develop and implement SOPs for Production Documentation and APQR activities.
  
• Ensure compliance with BPR review, Change Control, Deviation, Capa processes.
• Audit exposer like USFDA/MHRA/EU GMP.