Quality Assurance

3 days ago

Bharuch, India Anshika Polysurf Ltd Full time

Managing quality products, Vendor development, RM approval, Equipment maintenance and certification.
- Making of Specification, SOP, WI, TDS, SDS etc.
- Improvement, GLP, House Keeping, Customer quarry & rectification, Product Stability reports, OOS, OOT, NC, CAPA, Rectification, Training, Vendor audit, QC management, QA management.
- Handling IMS-QEHSEn, GOTS, HALAL, REACH, KOSHER, FDA, AUDIT
- 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

**Salary**: ₹300,000.00 - ₹600,000.00 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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