Title:  SECTION HEAD - BATCH RELEASE

SECTION HEAD - BATCH RELEASE                         

POSITION SUMMARY

• Responsible for IPQA activity and strategy in line with Sun Pharma Compliance, Product Quality Management objectives and Regulatory requirements.
• Responsible for planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or Procedures. Identify and implement solution for improving existing site quality assurance systems and processes
• Involvement in co-ordination of activities for software like SAP HANA at plant
• Responsible for review and Approval of Quality management/GMP records.
• Responsible to ensure and perform site data review of batch records for completeness of documentation, approval and rejection of materials per current good manufacturing procedures and escalation of quality incidences, Continuous process verification (CPV). Manage the batch release function at site wrt documentation, systems, approval and rejection of materials, products at the Site per current Good Manufacturing Practices requirements.
• 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 Global Quality Policies, Standards and Procedures.

Key responsibilities:

1.  Ensure compliance to regulatory requirements on product, process, equipment and release procedures.
2.  Manage Batch release activities for commercial dispatch.
3.  Escalate compliance concern to concern stakeholder.
4.  Review, compliance of BPR and batch release for commercial dispatch.
5. Review and approve the investigations, CAPA, and effectiveness checks with adherence to timeline.
6. Execute change control and risk assessment whenever required.
7.  Ensure Quality Metrics, Quarterly BPR report as per specify timeline.
8.  Ensure timely Batch release through electronic system.
9. Planning and arranging for internal and external departmental support of Quality Assurance activities as directed in approved protocols, quality systems or Procedures.
10. Follow the EHS policy and maintain the compliance to GMP requirements.
11. Co-ordination with QPs and customers of different region for batch release.
12. Management of Technical agreement with QP and Customers.
13. Responsible for oversight in warehouse and BSR.
14. Management of retain sample storage , inspection and life cycle management.

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS

• M.sc / M. Pharm/ B. Pharm
• 15 years with work experience preferred.

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

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS

Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required.