Manager Batch Certification

Year    Dadra, Dadra & Nagar Haveli, India

Job Description


POSITION SUMMARYManage overall batch certification review of QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, instrument preventive maintenance/ calibration/ qualification/ validation as per good manufacturing practices/ good documentation requirements and ALCOA++ principles).The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP\' s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.Key responsibilities:

  • Lead the review of all QC records related to Batch certification program.
  • Review Deviations, CAPAs, OOS/OOT investigations,
  • Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc.
  • Review initiated CAPA records related to QC investigations for completeness and adequacy.
  • Review and approval of qualification, analytical method transfer, validation protocol and reports for accuracy, completeness and traceability as well as adherence to the Protocol/procedures.
  • Training of QC and QA teams.
  • Work in partnership with Quality Control and Quality Assurance
  • Follow the EHS policy, laboratory procedures and maintain the compliance to cGMP requirements
MINIMUM EDUCATION/EXPERIENCE REQUIREMENTSScience or Pharmacy Graduate or Equivalent8yearsREQUIRED SUCCESS ATTRIBUTE
  • Knowledge of GxP\'s, cGMP and other regulatory requirements.
  • Planning and Prioritization
  • Collaboration
  • Accountability
  • Compliance
  • Customer Service orientation
Secondary Success Attributes
  • People Connect
  • Attention to detail
  • Emotional control
  • Effective Communication & Problem solving

Sun Pharmaceutical Industries

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Job Detail

  • Job Id
    JD3361886
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Dadra, Dadra & Nagar Haveli, India
  • Education
    Not mentioned
  • Experience
    Year