Senior Executive-QA

piramalpharma

Digwal

On-site

INR 600,000 - 900,000

Full time

33 hours ago
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Job summary

Piramal Pharma Solutions is seeking a Senior Executive QA to oversee auditing, data review, and release processes for intermediates and finished products. The role focuses on maintaining GMP-compliant QA records and ensuring instrument data integrity.

The position requires MSc in a related field and experience in QC/QA environments. Responsibilities include audit trail reviews, logbook verification, and incident reporting within a robust laboratory setting.

Qualifications

  • MSc degree in a relevant science field is required.
  • Strong analytical and data review skills.
  • Experience with QA in analytical environments is preferred.

Responsibilities

  • Review audit trails of chromatographic and non-chromatographic instruments.
  • Review and release analytical data for intermediates, finished products, stability data and IPC data.
  • Release of intermediates and finished products.
  • Review system audit trails of QC instruments.
  • Verify various logbooks for completeness in QC area.
  • Invalidate analytical data when necessary.
  • Identify and report potential contamination or cross contamination.
  • Verify SOPs compliance on the shop floor.
  • Carry out audits for laboratory system compliance.
  • Report incidents/near misses to superiors.

Education

Master of Science (MSc) in a relevant field

Tools

Chromatography instruments

Job description

Division

Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle.

We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms.

We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Executive-QA Job Description

  • Review of Audit trails of the Chromatographic instruments and Non chromatographic instruments.
  • Daily review and release of analytical data of intermediates, finished products, stability data and IPC data Responsible for the review of In-process analytical data before release.
  • Responsible for the review of Intermediates, stability batches and Finished products before release.
  • Responsible for the release of Intermediates and finished products.
  • Responsible for the review of System audit trails of the instruments in QC.
  • Verification of various logbooks for completeness in QC area.
  • Responsible for the invalidation of the analytical data.
  • Identify and report the potential areas of contamination/Cross contamination.
  • Verifying the SOP's compliance in shop floor.
  • Carry out the audits as and when required for laboratory system compliances.
  • Report any incident/accident/near miss to the superiors.
  • Master of Science (MSc)
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