Officer - Quality Control / Quality Assurance

3 weeks ago

Nashik, India VIATRIS Full time

Role: Officer - Quality Control / Quality Assurance

Job Location: Nashik

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via:

  • Access Providing high quality trusted medicines regardless of geography or circumstance;
  • Leadership Advancing sustainable operations and innovative solutions to improve patient health; and
  • Partnership Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how this role, will make an impact:

Role Purpose

We have Openings in Both QC (Lab / Microbiology / CSV) and QA(IPQA / Documentation / QMS / AQA) .

Seeking for candidates (Male/Female) with sound qualification background to ensure the testing of drug product in Quality control lab and to ensure every product is of the highest quality. They shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are carried out under the norms of cGMP.

Role & responsibilities

  • Candidate must have relevant experience in Quality control OSD and QMS and able to operate & maintain laboratory equipment/instruments (HPLC, GC, Malvern Particle sizer, dissolution apparatus etc.) as per procedure.
  • To maintain documents as per GLP requirements.
  • To ensure the calibration status of laboratory equipment & instruments.
  • To report and involve in incidence/Deviation/OOS/OOT investigations.
  • Candidate must have sound exposure in the Quality Control Laboratory to supervise and maintain documents and retention of records as per GMP requirements.
  • To ensure the review of QC documents like analytical reports SOPS, Qualification, Logbooks, Raw data sheet, analytical records, calibration and ensuring compliance to observations with proper root cause and justifications.
  • Candidates participate in initiation, review, and closure of OOS/OOT and monitor the CAPA with implementation in Track wise.
  • To ensure the compliance of the Corrective and Preventive Actions (CAPA) necessitated through various activities such as Regulatory Audits, Market Complaints, and Product Recall & Annual Product Review in the QC if applicable.
  • To support Quality Assurance / Compliance /Regulatory Systems, Processes and ensure Monitoring, Execution, Initiation of the Quality Management Systems in Quality Control laboratory.

Qualification & Experience

  • Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry
  • Experience- Candidate must have 1 to 4 years experience in a reputed pharma industry.
  • Candidates must be willing to work in shifts
  • Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.

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