Job Description

Executive recruitment company Monroe Consulting Group Malaysia\'s Industrial Division is recruiting on behalf of a leading pharmaceutical company that innovates and revolutionises new solutions for everyday treatment to treat patients across 120 different countries. As the business continues to grow and expand, our respected client is seeking a dynamic, technical and experienced individual for the job of an Associate Manager for Downstream Production. The opportunity is based in Johor, Malaysia.

:

• To monitor the compliance with the requirements of Good Manufacturing Practice
• Ensure that the batches are manufactured as per production plan without any delays
• Adherence to the standard operating procedures and ensure the team is following the defined procedures
• Production planning and inventory control: Responsible for ensuring the availability of Raw material prior to start of batch
• DS dispensing in coordination with team and ensure timely release of batches
• Ensure the GMP documents are reviewed and submitted to QA as per the SLA
• Investigation of non-conforming/Deviations/OOS/OOT and implementation of CAPA. To ensure these documents are closed on time as per SLA
• Ensuring to maintain the qualified status of all the production equipment in coordination with CFT
• Regular maintenance of production equipment in coordination with engineering and maintenance department
• Planning for CAPEX and OPEX requirements
• To initiate, coordinate and verify the CAPA taken against the nonconformance observed during the audit
• Guiding the team members in the preparation, hazard and risk assessment register, aspect/impact register and reviewing the adequacy
• To follow the established procedures and policies of the company pertaining to EHS and ensuring effective implementation of EHS management system. Reviewing the progress/status of EHS objectives & targets periodically
• Responsible for giving objectives and proper utilization production personnel
• Training and evaluation of production personnel and there by minimize the manual errors
• Adherence to plans towards execution of commercial, clinical, and developmental campaigns in compliance to pre-defined Quality and Safety procedures
• Responsibility of functions and the people for continuous improvements in both functional competencies, career tracks and employee engagement
• Establish product Life cycle management through validation cycle and continuous improvements towards high throughput. To maintain the quality and robustness of the process
• As and additional responsibility to involve for all the activities related to Downstream purification -1, Downstream purification -2 and Buffer Preparation Area
• To ensure availability of Personnel and schedule the requirements accordingly
• Responsible for OTIF execution of all the activities related to Downstream purification-1 and Buffer Preparation area as per the production plan
• To have a visibility on SAP operations and get trained on basic requirement

• Must possess at least Bachelor\'s Degree or Master in Biotech, Bioprocess & Chemical engineering, and related discipline or equivalent.
• Candidate should understand chemical process in bio-product manufacturing.
• Pharmaceutical background is preferred.
• Candidates with experience in MSAT and CQV are preferred.
• Good presentation and communication skills.
• Good problem solving and analytical skills.
• A strong team player with good planning and interpersonal skills
• Good command in both spoken and written English and Bahasa Malaysia

Monroe Consulting