Job Description

Executive recruitment company Monroe Consulting Group Malaysia\'s Health Division is recruiting on behalf of a leading MNC in Pharmaceutical. Our esteemed client has a global presence and manufactures various pharmaceutical products to treat patients across 120 different countries. We are seeking a talented Senior Quality Manager to join our client team who based in Johor Bahru.

Job Responsibilities:

• Responsible for review and approval of SOPs, Batch Manufacturing Records, Batch Packing records, Study Protocols, Study Reports and other GMP documents as applicable.
• Ensure process validations, cleaning validations, hold time studies, transport validations and product related validations as planned are executed as per laid down procedures and schedules.
• Ensure compliance of issuance, control, review, reconciliation and retrieval of GMP documents like Batch Manufacturing Records, Batch Packing Records, Dispatch Records, Format, logs during manufacturing operation.
• Responsible for the monitoring of manufacturing operations as quality assurance to ensure that activities are carried out as per laid down instructions in Batch Documents, Standard Operating Procedures and related GMP documents. Do ensure that highest quality and cGMP standards, data integrity requirements are followed during daily operation at shop floor.
• Perform batch release activity as when required.
• Strategic planning and scheduling of work activities among the team members of Quality Assurance and coordination with cross functional teams to ensure cGMP compliance on daily routine operation at shop-floor.
• Conduct GMP rounds /GEMBA and report the observations as per procedure.

• 10+ years of experience in Manufacturing Quality in Pharmaceutical, Chemical, Medical Device and FMCG.
• Open to relocate to JB/Johor Bahru.
• GMP/cGMP practices experience; is a must.
• Strong leadership skills and ability to manage a team of direct reports.
• Ability to make effective decisions and manage budgets.
• Strong analytical and problem-solving skills.

Monroe Consulting