QMS Documentation officer MSC chemistry

4 weeks ago

Bangalore Rural, India Infinitalent Consulting (P) Ltd Full time

Company Overview


Infinitalent Consulting (P) Ltd is the best-rated HR consulting firm in Bangalore. We are a preferred recruitment partner, specializing in permanent placements and temporary staffing for various industries. Our primary focus is matching the right talent to the right job opportunities.


Job Overview


We are hiring a QMS Documentation Officer with an MSC in Chemistry. This is a full-time role with 1 to 3 years of experience. The job location is Bangalore Rural, Karnataka, India. As a QMS Documentation Officer, you will be responsible for ensuring compliance with quality management system standards and documenting all quality-related processes.


Qualifications and Skills


  • MSC in Chemistry or a related field
  • 1 to 3 years of experience in a similar role
  • Strong knowledge of quality management system standards
  • Experience with document control and QMS documentation
  • Ability to work independently and collaborate with cross-functional teams
  • Excellent attention to detail and organizational skills
  • Good communication and interpersonal skills


Roles and Responsibilities


1. Handling quality events in production department. i.e., Change Control, Deviation, OOS, OOT, CAPA and investigation.

2. Preparation of Equipment Performance qualification protocol and report.

3. Provide data to QA to prepare Process Validation Protocol and report.

4. Preparation of Batch Manufacturing Record (BMR), Master Formula Record (MFR) and Standard Operating Procedures (SOP) related to Production department.

5. Coordinate the preparation, review, approval, and distribution of production-related documents, including BMRs, SOPs, investigation reports, and Change control forms.

6. Train production staff on SOP, BMR, CAPA and proper documentation practices.

7. Collaborate with cross functional teams such as R&D, QC, QA, Maintenance, stores and Commercial for data collection and document review. Participate in quality reviews and investigations as needed.

8. Support internal and external audits and inspections by preparing documentation, facilitating document retrieval, and addressing auditor inquiries.

9. Maintain the storage, retrieval, and archival of production documentation. Ensure documents are stored securely and are readily accessible for audits, inspections, and other quality assurance activities.

10. Review of Batch manufacturing record & batch packing record for completeness weekly basis.

11. Review of production log books like equipments usage log book, Clean room usage log book, weighing balance Performance log books and Daily Humidity recording log book.

12. Co-ordination with external agency for calibration of Production department Temperature and relative humidity instruments, weighing balances and standard weights.

  • 13. Taking line clearance for clean room from QA for product change over.





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