Title:  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:

1.  Lead the review of all QC records related to Batch certification program. 
2.  Review Deviations, CAPAs, OOS/OOT investigations,
3.  Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc.
4.  Review initiated CAPA records related to QC investigations for completeness and adequacy.
5.  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.
6.  Training of QC and QA teams.
7.  Work in partnership with Quality Control and Quality Assurance
8.  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

Secondary Success Attributes

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