Manager Batch Certification

Position Summary

Manage 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 Requirements
• Science or Pharmacy Graduate or Equivalent
• 8years

Required Success Attribute

• Knowledge of GxP’s, cGMP and other regulatory requirements.
• Planning and Prioritization
• Collaboration
• Accountability
• Compliance
• Customer Service orientation

• People Connect
• Attention to detail
• Emotional control
• Effective Communication & Problem solving