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Date: Oct 24, 2017

Location: Singapore, SG

Company: MSD

Requisition ID: QUA006438


  • Responsible for all aspects of Quality Laboratory including Raw Material, Packaging Components, Excipients, In-Process, Intermediate, Semi-Finished Products, Drug Substance and Final Drug Product Testing, Facility Equipment Cleaning, Laboratory Investigations and Annual Product Review.

  • Lead and support laboratory related investigations and ensures closure in accordance with MSD guidelines, sound logic and cGLP. Responsible for the execution of robust and sustainable Corrective and Preventive Actions in a timely manner.

  • Provide guidance for updates of relevant documentation to ensure regulatory compliance and takes a leadership role in ensuring compliance to appropriate regulations and corporate standards.

  • Participates in drug product and drug substance analytical development and testing support for all late stage and marketed drug candidates manufactured in MSD Singapore as required.

  • Support the generation of CMC information for IND amendments and regulatory filings to support marketing approvals as required.

Responsibilities



  • Reviews and Approves cGMP documentation, including Item Master Forms, SOP, Job Aids, Forms and Procedures.

  • Reviews and Approves investigations to ensure it is thoroughly conducted and meet the standards set in the SOP.

  • Ensures standard lead time is followed for Raw Material, Packaging Components, Excipients, In-Process, Intermediate, Facility Equipment Cleaning samples, Semi-Finished Products, Drug Substance, and Final Drug Product testing.

  • Participates in the daily IPT walk-through and supports the resolution of identified issues and/or unplanned activities.

  • Reviews Annual Product Review and guides chemists to prepare the Annual Product Review packages.

  • Leads and supports method transfers, method verifications for Raw Material, Excipients, Intermediate, Drug Substance, Final Drug Product, and Cleaning.

  • Participates and responds to IQA, Regulatory & Safety audit observations.

  • Reviews and approves the implementation of new and revised Quality Standard and Standard Analytical Techniques.

  • Ensures all direct reports, contract staff receive required cGLP, cGMP, SHE, and role-related training required to work safely and in compliance with regulatory requirements and as defined by their training matrix.

  • Proactively supports cGMP compliance, permanent inspection readiness, identification of compliance risks and breaches.

  • Ensures all work group activities are completed according to established procedures, all associated documentation is completed to a high standard, accurately, and in compliance with regulatory requirements.

  • Improves "Right First Time" performance through deviation reduction and the provision of error-proofed documentation.

  • Ensures documentation is made available during regulatory inspections, provides technical expertise as a lead auditee, and implements corrective actions as required following regulatory inspections and internal audits.

  • Develops a continuous improvement framework within the team, identifies and implements projects and improvements, actively supports site improvement programs to increase accuracy, compliance, productivity, and also reduce cycle time, inventory and waste.

  • Effectively manages and plans labor utilization, minimizes overtime usage, and promotes a culture of low absenteeism.

  • Manages manpower deployment to ensure optimal efficiency to meet lab operational requirements.

  • Responsible for all staff's performance appraisals, developmental plan and coaching.

  • Ensures all direct reports, contractors staff are trained on SHE policies and guidelines and ensures that the team works in compliance with SHE requirements.

  • Ensures that the safety measures associated with chemical handling and equipment guarding etc. are satisfactory and in good working conditions.

  • Prepares and managers capital and expense budgets for the labs under his/her responsibility and operates within budget.

Qualifications


  • Bachelor Degree or higher in Chemistry/ Biochemistry.

  • Minimum 7 years of experience in Pharmaceutical or Manufacturing Laboratory.

  • Experience in Laboratory operations management, problem solving, developing and implementing technical solutions, laboratory start-up, project management.

  • Demonstrates knowledge and application of sound scientific principles, theories, techniques and skills.

  • Experience in Lean Six Sigma Methodology, application of Lean Tools would be an added advantage.


Job: Quality Lab Related
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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