Opportuntiy to work as Senior Manager at Sun Pharmaceutical – Apply before 20th July 2024

Sun Pharma

Website Sun Pharmaceutical

About Sun Pharmaceutical

It is an Indian multinational pharmaceutical company headquartered in Mumbai, India. It is one of the largest pharmaceutical companies in the world by market capitalization and revenue. Sun Pharma manufactures and markets a wide range of pharmaceutical formulations and active pharmaceutical ingredients (APIs) in various therapeutic areas including cardiology, psychiatry, neurology, gastroenterology, and oncology, among others. The company has a global presence with operations in over 150 countries and a strong focus on research and development to introduce innovative and affordable healthcare solutions.

Job Posting: Sr. Manager – CMO at Sun Pharma

Job Description

Job Summary

  • Role: Sr. Manager – CMO
  • Objective: Responsible for quality oversight of contract manufacturing organizations (CMOs) handling site transfer products (Sun site & R&D) for the US market.

Essential Job Functions

  • Oversight Visits: Conduct regular visits to CMO sites to review processes and practices, and prepare detailed visit reports.
  • Coordination: Act as the Single Point of Contact (SPOC) between Sun Pharma site, commercial, corporate quality audit teams, and the CMO site for product manufacturing, release activities, and technical issues.
  • Quality Agreements: Author and review quality agreements between Sun Pharma and CMO sites, ensuring the use of qualified and approved external service providers.
  • Manufacturing Participation: Ensure presence and active participation during manufacturing for process validation batches to confirm adherence to the approved Batch Manufacturing Record (BMR).
  • Testing Supervision: Witness and oversee testing of process validation batches, including hold time studies and in-process testing, in compliance with approved specifications, test procedures, and protocols.
  • Document Review: Regularly review quality system documents, facilities, equipment, manufacturing and packing controls, labeling, and laboratory controls at CMO sites.
  • Cause-Based Visits: Conduct routine and cause-based visits to CMO sites to address market complaints, recalls, Corrective and Preventive Actions (CAPA) implementation, and effectiveness checks.
  • Batch Review: Review batch manufacturing and packaging records, analytical reports, Certificates of Analysis (COA), and Certificates of Conformance (COC) for batch release, and manage batch release in SAP.
  • Data Review: Review stability data, process validation reports, analytical method validation reports, specifications, Standard Test Procedures (STP) for finished products, API COA, primary packing material COAs, and approved vendors for raw materials/packaging materials.
  • Quality System Documents: Review change controls, deviations, CAPA, Out of Specification (OOS)/Out of Trend (OOT) results, product quality complaints, and recalls.
  • SOPs Preparation: Prepare and review Standard Operating Procedures (SOPs) according to Sun Pharma quality standards.
  • Vendor List Preparation: Prepare an approved vendor list for raw materials and primary packaging materials for products manufactured at CMO sites.
  • Risk Assessment: Conduct annual risk assessments of CMO sites.

Candidate Profile

  • Educational Qualification: M.Sc./B. Pharm/M. Pharm or equivalent.
  • Experience: 15-18 years in Quality Control, Quality Assurance, and compliance within sterile formulations manufacturing.
  • Regulatory Knowledge: Comprehensive knowledge of Good Manufacturing Practices (GMPs) in domestic and international regulatory environments. Proficiency in FDA guidelines and ICH standards is essential.
  • Skills: Strong organizational, interpersonal, and communication skills. Ability to work effectively in a multicultural matrix organization.

Additional Information

  • Experience: 15-18 years
  • Qualification: M.Sc./B. Pharm/M. Pharm
  • Location: Mumbai / Baroda
  • Industry Type: Pharma/Healthcare/Clinical Research
  • Department: Corporate Quality
  • End Date: 20th July 2024

Join Sun Pharma, a leader in pharmaceutical innovation and quality, and contribute to our mission of improving healthcare globally. Apply now!

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To apply for this job please visit careers.sunpharma.com.