Posted:2 days ago|
Platform:
Work from Office
Full Time
Role & responsibilities 1. Responsible to lead functions of Quality Control department at site. 2. Responsible to establish, implement and maintain Quality Control department in the state of compliance with statutory and regulatory expectations. 3. Responsible to ensure data integrity in quality control laboratory. 4. Responsible for handling Internal/External/Regulatory audits in Quality Control department at site. 5. Responsible for Preparation/ review of Compliance Report and appropriate CAPA implementation w.r.t. quality control observations or recommendation of Internal/External/Regulatory audits at site. 6. Responsible for timely investigation and closure of laboratory incidents, OOS, OOT, change control, deviation, CAPA etc. 7. Responsible for imparting training for effective implementation of quality system in quality control laboratory. 8. Responsible for review and approval of GMP documents of Quality Control. 9. Responsible to ensure timely testing and release of RM, intermediates and Finished goods. 10. Responsible for stability study Management and Management of retention Samples in quality control laboratory. 11. Responsible for qualification of new instruments/Equipments in laboratory. 12. Responsible to resolve queries raised from Internal and External stakeholders. 13. Responsible to organize and plan method transfer activities in quality control laboratory from R&D. 14. To ensure Updation of Spec/STP/SOP against Pharmacopeial changes & Regulatory requirements. 15. Responsible for coordination with external vendors and service engineers as and when required. Preferred candidate profile Candidate must have experience in API Industry (Kindly don't apply if you don't have experience in API). Perks and benefits Salary no bar for deserving candidate.
Akums
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