Manager QA
On-siteAll, Catalunya, Kingdom of Spain
All, Catalunya, Kingdom of SpainOn-siteFull TimeSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Oversee Quality operations across Bulk Manufacturing, QC, Engineering, IT, and Warehouse, including review and approval of SOPs, URS, DQ, IQ, OQ, and PQ protocols. Manage deviations, change controls, CAPAs, and GMP compliance while coordinating with external agencies like CDSCO and NIB. Control raw material handling, validate transport and thermal cycles, and lead failure investigations for OOS/OOT events. Monitor water and EMP trends, oversee computer system validations, and ensure audit closure with cross-functional teams. Coordinate management reviews, track quality metrics, and support regulatory filings to maintain site Quality Index targets.
Required Qualifications
- M.Sc. Biotechnology/Biochemistry
- 10+ years' experience in QA
- Review & Approval of SOPs pertinent to Bulk manufacturing, Engineering, Warehouse, Quality Control, IT and other general areas
- Review & Approval of URS, DQ, IQ, OQ & PQ protocols pertinent to Bulk manufacturing, Engineering, Warehouse, Quality Control and other general areas
- Handling of Deviations, Change Controls & CAPAs pertinent to Bulk Manufacturing areas, Quality Control, Engineering, Warehouse and Housekeeping areas
- Control and reconciliation of Research, Master / Working Cell Banks and maintenance of relevant documentation
- Review of specifications and testing protocols of material / product pertinent new / existing product and new introductions
- Review / verification of executed BMRs and batch release checklists till Drug substance stage
- Review of Study protocols like PV/CV/Change over, oversight of study execution, compilation of data, review & approval of reports
- To ensure completion of Transport Validation activities, Thermal cycle study and Bio-burden Validation activity for each product as per SOP and Validation Master Plan
- To handle Failure investigation of Unplanned Deviations / Out of Specifications (OOS) / Out of Trends (OOT) and approve the same
- Periodic review of Water & EMP trends, investigations and to ensure actions proposed are implemented
- During Internal & External audits, GMP compliance, minimization of observations and further compliance verification
- Continuously upgrade skills of self and subordinates through training to ensure the jobs are performed effectively
- To review, coordinate, monitor and ensure the closures with the cross functions at the site regarding audit schedules, audit findings, corrective actions, trainings and audit compliance reports
- To review and approve the Self-inspections (internal Audits) plan
- To ensure compliance to Retention/control sample management and document cell management in line with SOP
- To ensure updation of control limits for Out of Trend results for Drug Substance / Intermediate
- To respond to the marketing & Production Planning queries and provide data to Regulatory department for regulatory filing and annual amendments
- To ensure that Stability schedules, Stability/Holding time study Protocols and initiation of modification or discontinuation of stability/Holding time study protocols for intermediates as per SOP
- To ensure that applicable GQS/GSOPs implementation and tracking at site
- To review and ensure all the Computer System Validation / Process Control Systems against applicable GSOPs / site SOPs
- To review / approve the systems inventory, user access of all the computer systems at site
- Management Review meetings, action items tracking and compliance to meet the market demands for continuous supplies
- To ensure the Quality Metrics data related to scoring / monitoring as per the defined template by Corporate governing team
- To ensure continuing suitability and effectiveness of pharmaceutical quality system through management reviews/Policies/Procedures
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