Title:  QMS Manager / Senior Manager

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