Title:  Senior Manager - QA

3 POSITIONS:

1. Manager/Senior Manager QA

Location: Halol 1

Designation: Manager 1/Senior Manager 2

Education: B. Pharma/ BSc / B.Tech

Experience: 15+ Years in QA functions of sterile QMS

JOB DESCRIPTION:

Key Responsibilities:

• Handling of market complaints received at site. Responsible for ensuring market complaints, failures, deviations are investigated and corrective and preventive actions are implemented as per set timelines.
• Review of complaints for FAR assessments and communications to Corporate Quality and US team.
• Annual Product Review/Product Quality Review management, review and approval including annual calendar.
• Ensuring management notification (Quality alerts) are effectively managed and timely notified.
• Conducting internal quality audits. Facilitate internal and regulatory agency audits, ensuring that findings from site audits are understood, assessed and addressed site wide in a comprehensive manner.
• Review of monthly report/Quality index and track Quality metrics for sustaining Site Quality Index.
• Coordination with regulatory and other department regarding QA activities.
• Approval/rejection of GMP document.
• To review and authorize documents related to QA department in absence of Site Quality Head.
• Internal and external communication related to QA Activities.
• Ensuring trained, aligned staff at appropriate staffing level and motivational environment for the staff.
• Coordinating for health hazard evaluation reports with Corporate Quality and Pharmacovigilance.
• Recall related communications to respective coordinator as per market.
• Facilitate review and implementation of Global documents (GQS/GSOP).
• Ensure changes are driven through change management program and effectively implemented.
• Handling of departmental employee training programme.
• Monitor industry trends/issues faced internally and identify scope for improving Site quality assurance management and processes.
• Responsible for executing Quality Management Reviews at site, monitor individual performance and set improvement areas.
• Identify and implement solution for improving existing site quality assurance systems and processes.
• Define site quality assurance goals and strategy in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.
• Coach and develop both direct and, as appropriate, indirect reports through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities.
• Effectively manage the site Quality Assurance activities and resources necessary to smoothly run the QA operation at site.
• Perform all work in support of our Corporate Values of Pride, Accountability, Integrity, and Diligence. Perform all work in accordance with all established regulatory and compliance and safety requirements.

Tasks:

Will be authorized to sign(as review or approver):

• Market Complaint reports.

• Change Control records

• Planned Modification records

• Corrective Action Requests

• Incident / Investigation Reports

• Annual Product Reports/Product Quality Review Report

• Standard Operating Procedures

• Master Batch Manufacturing Records / Packing Records

• Protocols and reports

• Internal Quality Audit Reports

• Product recall forms

• Field alert reports

• Training Documents

• Certificate of Compliance

• Risk Assessment reports

• Destruction Notes

• Quality alerts

• Trackwise Records

• Health hazard evaluation request forms

• Forms related to Global Quality documents (GQS/GSOP)

• Other GMP, Regulatory, Administrative and Commercial documents

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2. QA Block Head

Location: Halol 1

Designation: Senior Manager 2

Education: B. Pharma/ BSc / B.Tech

Experience: 18+ Years in sterile operations

KEY RESPONSIBILITIES:

Overall department-level Quality system leadership in execution.  Foster daily support and QA oversight activities in operations.  Primary QA working-level responsibility.  Must provide proactive and response-driven leadership.  Open communication with operations Executive level is essential.  Provide back up to QA Head as assigned.

Approval authority:

• Commercial product

• Incident and investigation closure

• CAPA plans and closure

• Protocols

• Reports

• Change control

• Standard Operating Procedures

• MBMR / MBPR

• Coordinating the QA activities on shop floor activities.

• Providing support to quality management system.

• Review and approval in QMS software in Track Wise.

• Review authority for other QA documents such as master plans, risk assessment reports, APR reviews or audit response

• Active participation on CEP steering committee and assure effective implementation:

• Schedule execution and reporting

• Set guidelines to standardize the CEP improvement process for consistency

• Escalation of any concerns to schedule or resolution of action items

• Primary QA liaison to Production manager for continuous improvement

• Participate in internal quality audits

• Provide block Quality metrics data.

• Escalate compliance concerns to management

• Audit performance of QA Executives

• Delegate responsibilities and internal and external resources to CEP activities

• Partner and audit for Production training effectiveness.

• QA activity priority management.

TASKS:

• Has responsibilities of sterile manufacturing Quality Assurance:

Will be authorized to sign (as reviewer or approver):

• Market Complaint reports.

• Change Control records

• Planned Modification records

• Corrective Action Requests

• Incident / Investigation Reports

• Annual Product Reports/Product Quality Review Report

• Standard Operating Procedures

• Master Batch Manufacturing Records / Packing Records

• Protocols and reports

• Internal Quality Audit Reports

• Product recall forms

• Field alert reports

• Training Documents

• Certificate of Compliance

• Risk Assessment reports

• Destruction Notes

• Quality alerts

• Breakdown documents

• Other GMP, Regulatory, Administrative and Commercial documents

• Trackwise Records.

• Effective manpower planning

• Training programs for QA

• Sign/Approval of GMP documents as QA Head designee as and when required.

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  3. 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.