Executive

Lupin

8 - 10 years

7 - 11 Lacs

Pune

Posted:2 hours ago| Platform:

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Skills Required

method validation risk assessment pharmaceutical analytical production ipqa hplc oos qc oot review qms api gc chemistry uv capa quality control deviation assurance analytical method validation process validation quality assurance pharmacy investigation cleaning validation

Work Mode

Work from Office

Job Type

Full Time

Job Description

To review/approval/closure, rejection/drop (if required) of Quality system documents such as Deviation, change control, CAPA, OOS, OOT, Re-process & Re-work, market complaint, market returns & LIR.
To ensure & handle the investigation for Out of Specification Results, OOT, Deviations, Product failures and Market Complaints are adequately performed and documented with appropriate Quality Risk Assessment activity, Corrective and Preventive Actions based on the results of the investigations are identified and implemented.
To preparation review & Approval of Quality system trend.
To verify In-process Quality Assurance during production activity and sampling at different stages of processing/packing as per requirement.
To review & approval of API Analytical Method Transfer Protocol/Report and method validation documents.
Preparation & review of Annual Product Quality Review.
Preparation, Review & Approval of Hold Time Study Protocol/Reports, and other study protocols/reports

Work Experience

7-9 year

Education

Masters in Science or Pharmaceutical Chemistry

Post Graduation in Pharmacy

Competencies

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