Quality Assurance ( Bharuch )

Year    Bharuch, Gujarat, India

Job Description


  • 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
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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Job Detail

  • Job Id
    JD3062095
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Bharuch, Gujarat, India
  • Education
    Not mentioned
  • Experience
    Year