Overview
QMS Manager/Senior Manager Jobs in Indiana, Pennsylvania, USA at Sun Pharmaceutical Industries, Inc.
Position: QMS Manager / Senior Manager
Company:
Sun Pharmaceutical Industries Ltd
Location:
Halol 1
Education:
B. Pharma/ BSc /
B.Tech
Experience:
15+ Years in QA functions of sterile QMS
JOB DESCRIPTION:
Key Responsibilities:
Handling of market complaints received ponsible 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 departments regarding QA activities.
Approval/rejection of GMP documents.
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):
Incident / Investigation Reports
Annual Product Reports/Product Quality Review Report
Master Batch Manufacturing Records / Packing Records
Protocols and reports
Internal Quality Audit Reports
Field alert reports
Certificate of Compliance
Quality alerts
Forms related to Global Quality documents (GQS/GSOP)
Other GMP, Regulatory, Administrative and Commercial documents
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Title: QMS Manager/Senior Manager
Company: Sun Pharmaceutical Industries, Inc.
Location: Indiana, Pennsylvania, USA
Category: Quality Assurance – QA/QC, Healthcare
