Schering-Plough is a global science-based healthcare company with leading prescription, consumer and animal health products. Through cutting edge pharmaceutical technology research, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important unmet medical needs.

Schering-Plough Singapore has one of the most diverse and ever expanding pharmaceutical manufacturing profiles in the country, producing a wide range of pharmaceuticals, including active drug substances, tablets, dry powder inhalers, sterile injectables and nasal sprays. It is a key site in the Schering-Plough Global Network that offers exciting opportunities for career progression.

Responsibilities:

• Purpose and Scope of Job:
• Support and supervise a group of senior / microbiologists and coordinate microbiological testing and associated resource needs on day to day basis for Biotech Microbiology Laboratory that supports the sterile operation within Biotech facility.



• Key Responsibilities:
• Assign daily work task and supervise a group of Microbiologists.
• Support and provide technical information pertaining to microbiological tests to lab management on routine basis.
• Review and approve test reports, log books, data sheets that are generated in microbiology lab.
• Review SOPs and Protocols with relevant to Microbiology.
• Review compendial and other site and corporate policy changes and ensure necessary change control for lab SOPs.
• Participate in trouble shooting activities for Utility systems and clean rooms.
• Conduct investigations for OOS and OOG results.
• Approve/Authorize additional testing/re-testing/re-sampling as appropriate, based on review of test results, Lab Investigation Reports &/or Materials Review Board.
• Initiate and review Variation Investigation as and when required.
• Participate in Production and Material Planning Meetings.
• Participate in Cross Functional Investigation Board and other relevant forum to represent Microbiology section.
• Involve in Ad hoc projects assigned by Lab management
• Coordinate in Method Transfer, Validation studies and Method Qualification Studies.
• Participate/ co-ordinate in Internal Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities.
• Coordinate with Quality Manager (Microbiology & Support) in performing periodic appraisal of Microbiologists.
• Coordinate with Quality Manager (Microbiology & Support) in Planning and Operation of the Department.
• Oversee the Calibration and Preventive Maintenance Programme.
• Ensure completion of periodic reviews of closed out validation packages and SOPs.
• Promote CI culture in the area to ensure sufficient and objective practices.
• Develop and manage a competency based training program for all Microbiology lab staff and provide coaching and mentoring for staff’s personal and professional development.
• Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Supervise and oversee Third Party Contractors, where applicable.
• Any other tasks as and when assigned by Quality Manager (Microbiology & Support).

Requirements:

• Candidate must possess at least a Bachelor's Degree or Master's Degree in Microbiology or Biotechnology.



• At least 5-7 years of working experience in the Pharmaceutical Industry including aseptic filling processes, with at least 3 years in Supervisory capacity, is required for this position.



• Candidates with good planning, good interpersonal skills, high integrity. analytical, methodical, organized at work, good ability to work in and lead a team, approachable and self-motivated and CI-minded.

We offer a competitive salary and benefits package as well as opportunities for career advancement. Please send your curriculum vitae, current and expected salaries to:

Human Resources
Schering-Plough LTD, Singapore Branch
50 Tuas West Drive, Singapore 638408

Website: www.schering-plough.com.sg

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Schering-Plough LTD, Singapore Branch
50 Tuas West Drive Singapore 638408