Laboratory Validation Chemist

at  Cipla

KEY ACCOUNTABILITIES (1/5)

• Provides support to quality control and manufacturing for resolution of analytical and quality related problems
• Works on Tech transfer projects.
• Responsible for ensuring GAP analysis and risk assessments are submitted on time for tech transfer products
• Drafts all protocols related to Analytical method development, method transfer, cleaning validation methods and method verification.
• Prepares tracker for AMD, AMV and AMT to be performed and report on progress on Monthly basis.
• Execute all protocols as per plan and tracker.
• Ensure staff is trained on the procedures.
• Logs CAPA, Deviations and Change controls and ensure they closed within stipulated time frame.
• Implements activities to prevent recurring of OOS and OOT attributed to QC function
• Trouble shooting
• Responsible for ensuring the integrity of all data and documentation reported from the Chemistry Laboratory.
• Reviews all source data for conformance to applicable specifications.
• Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made.
• Ensures investigations are assigned, completed and referenced for data or documentation, as appropriate, prior to release of Chemistry data.
• Interacts routinely with departments such as Production, RA, R&D, QA Validation team
• Assist in performing Quality Assurance audits on laboratory areas to ensure cGMP compliance.
• Assist in the investigation and review of deviation reports and OOS reports to assure complete and compliant source data.
• Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems.

EDUCATION QUALIFICATION

National Diploma / BTech Degree and or B.Sc. in Analytical Chemistry/Biotechnology

RELEVANT WORK EXPERIENCE

4-7 years in a laboratory environment

The incumbent is responsible for planning, drafting protocols, execution and final reporting approval of Analytical Method validation (AMV), Analytical Method transfer (AMT) and Process Validation (PV) / special request (non-routine) samples in accordance with procedure.