Developed and implemented new analytical test methods.
Plan and execute internal and external audit,
Verified raw materials chemical/packaging, test results, batch yield, and insuring all documents are accounted for and complete.
Partnered with planning, production, and shipping to facilitate release of GMP products.
Prepared annual reports of FG products.
Included inspection of finished goods, stability results, fill weights, process capabilities, testing results, documentation, leaker/damage rates, returns/recalls/complaints.
Managed all laboratory functions including calibration of equipment, ordering of supplies and housekeeping.
Created report to set flags to alert readers of any impurities outside the limits.
Maintained batch and shipment sample retention based on customer needs
Routinely used analytical techniques such as HPLC, GC, UV, PSA etc to ensure samples and final products meet internal and external customer specifications.
Involved in troubleshooting process upsets and deciding the best avenue to resolve any issues that may arise.
Trained new employees on Quality Assurance systems, analytical methods, and instrumentation.
Conducted timely and effective laboratory investigations, OOS/OOT investigations and CAPAs (Corrective Action and Preventative Action plans), identify deviations and non-conformances in projects, in accordance with current GMP, FDA, and CFR regulatory requirement.
Communicated with laboratory personnel, supervisors and management on potential gaps or issues when identified.
Generated analytical data into LIMS system for accurate and traceable data.
Maintaining good laboratory practices and proper handling of instruments & chemicals.
Maintaining of QA lab procedures with its traceability to National / International standard.
Reducing hazardous waste generation, and fulfil environmental protection needs.
Coordination with related department Production, Commercial, despatch, Marketing, HO etc.
To ensure proper documentation to maintain all lab records (R&D, IP, RM, PM, FG, calibration, dispatch, solution preparation & normality) with proper entry in SAP, ERP
Qualification & Experience
B.Sc., M.Sc. (Chemistry) , B-Pharma, M-Pharma & MS office
Minimum 02 years - 05 years of working experience
An analytical mind with problem-solving skills
Excellent in Trouble Shooting.
Excellent organizational and multitasking abilities
A team player and able to work with all levels of Management
Job Type: Full-time Salary: 9300,000.00 - 9600,000.00 per year Schedule:
Day shift
Ability to commute/relocate:
Bharuch, Gujarat: Reliably commute or planning to relocate before starting work (Required)
Education:
Bachelor\'s (Preferred)
Experience:
working: 5 years (Preferred)
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