Urgent Opening For QA

13 hours ago

Ahmedabad, Gujarat, India Stallion Laboratories Full time ₹ 4,00,000 - ₹ 12,00,000 per year

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.

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