AddressPOSITION 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
10 years
REQUIRED 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
