QC Executive RM/ FG

6 days ago

Pithampur, Madhya Pradesh, India Piramal Pharma Limited Full time

Role Overview:

  • The Lab QA/QC Reviewer will be responsible for the comprehensive review and approval of analytical data generated by the QC laboratory.
  • This role ensures data integrity, compliance with regulatory guidelines, and facilitates resolution of quality investigations related to lab incidents.

Key Responsibilities:

  • Perform detailed analytical data review and electronic data verification for QC instruments including LCMS, HPLC, GC, Dissolution, Malvern 3000, etc.
  • Review raw data, chromatograms, and reports for accuracy, completeness, and compliance with SOPs and regulatory requirements.
  • Lead investigations related to QC laboratory incidents, including Out of Specification (OOS) and Out of Trend (OOT) results.
  • Ensure timely closure of deviations, CAPAs, and quality investigations related to analytical testing.
  • Collaborate with QC, QA, and Production teams to address and resolve quality issues.
  • Support preparation and execution of internal and external audits related to QC activities.
  • Maintain and update documentation related to data review and laboratory quality assurance.
  • Train and mentor junior QC analysts and review team members on best practices and regulatory expectations.

Preferred Skills:

  • Strong knowledge of pharmaceutical regulations, quality management systems, and analytical method validation.
  • Proficient in electronic data management systems and LIMS.
  • Excellent analytical, problem-solving, and communication skills.
  • Experience in managing QC investigations and regulatory inspections. .

Relevant Experience : Candidate should have good exposure of Analytical Data Review and electronic data review of QC instruments (LCMS/HPLC/ GC/ Dissolution, Malvern 3000 etc) . Should have Strong knowledge of QC investigations (Lab incidents, OOS/OOT etc)

Qualification: B. Pharma / M. Pharma / M.Sc. (Chemistry)

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