Executive QC – Quality Control Lead
SUN PHARMA · Halol
Job description
About the role
Sun Pharma is seeking an Executive – QC to lead quality control activities at its Halol manufacturing site. The role ensures that all pharmaceutical products meet regulatory standards and are released safely and effectively.
Key responsibilities
- Review and approve QMS documents such as OOS, OOT, lab events, deviations, change controls and CAPA.
- Validate and sign‑off routine analytical raw data for finished products, APIs, IP, PV and packaging.
- Maintain site readiness for regulatory inspections and internal audits, implementing corrective actions as required.
- Ensure compliance with cGMP, regulatory product, process and release procedures.
- Facilitate internal and external audits, track findings and drive site‑wide corrective actions.
- Monitor industry trends and identify improvements to the site’s quality assurance system.
- Review and approve SOPs, analytical COAs, test plans and stability protocols in EDMS and LIMS.
- Oversee release/approval of raw material and preventive maintenance in SAP HANA.
- Provide data for quality council, R&D, annual quality review and recall activities.
Required profile
- Graduate degree in Pharmacy, Chemistry, Biotechnology or related field.
- Extensive experience in pharmaceutical quality control and regulatory compliance.
- Strong knowledge of cGMP, QMS and audit processes.
- Proven ability to lead investigations, root‑cause analysis and CAPA implementation.
Required skills
- QMS
- cGMP
- LIMS
- SAP HANA
- EDMS
- CAPA management
- OOS/OOT investigation
- Method validation and transfer
- Instrument software: EWS, Empower, LabX
What we offer
- Opportunity to work in a leading global pharmaceutical company.
- Collaborative environment that encourages continuous learning.
- Career growth and development aligned with corporate values of pride, accountability, integrity and diligence.
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Published 1 month ago
Expires 2 weeks from now
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SUN PHARMA
Halol
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