Instrumentation & Automation - Drug Product, Senior Manager/Associate Director (Manufacturing), MY

Executive recruitment company Monroe Consulting Group's Industrial Division is exclusively partnered with multinational organization who is well established in the field of manufacturing.

Job summary:
The ideal candidate will be responsible in leading the IA Drug Substance functions to ensure smooth, uninterrupted, and safe facility operation while also being responsible for any Routine Breakdown, PM, CSV, Calibration, Mapping, and improvement projects.

Key job responsibilities include:

• Routine Breakdown, PM, CSV, Calibration, Mapping and improvement projects Direct and coordinate plant maintenance operations within company policies and procedures.
• Implement and ensure compliance to quality system. Implement and ensure compliance to EHS Ensure safe working environment and highlight safety needs.
• Planning and execution of Calibration and Validation activities of equipment and its accessories as per the schedule Review and Approve calibration and validation reports.
• Plan and execute preventive maintenance as per schedule.
• To write and review documents related to I&A and ensure their strict implementation. Implement Good Engineering Practices and Policies across the organization.
• Ensure functioning of IA Drug Substance teams within quality framework, follow up of quality SOP's and procedures, taking necessary measures to reduce engineering deviations.
• Providing CAPA's for deviations, proposing change controls, participating in equipment qualifications and validation.
• To monitor, track and ensure timely closure of all QMS elements.
• Prepare and propose annual CAPEX and OPEX budgets taking all necessary actions to ensure spends are within proposed budgets, developing budgets for maintenance improvements.
• Implementing necessary cost saving measures with no compromise on quality and productivity.
• Ensure maintenance of spares of all critical equipment in Drug Substance are available at all times.
• To ensure all planned preventive maintenance, calibration, qualification and requalification activities in Drug Substance are completed as per annual planners.
• Support commissioning & validation activities that include FAT/SAT/DQ/IQ/OQ and PQ.
• To recruit, manage and mentor IA Drug Substance personnel to maintain a motivated and effective team.
• Keeping management up to date on continual basis on critical data on Drug Substance plant / equipment and suggesting improvements / corrective measures if any.
• Ensure functioning of IA team in Drug Substance are following quality SOP's and procedures, taking necessary measures to reduce engineering deviations.
• Providing CAPA's for deviations, proposing change controls, participating in equipment qualifications and validation.
• To carry out Brown / Green field projects as and when required, involve in process optimization, plant / equipment up-gradation.

Key Job requirements include:

• Candidate must possess at least a Bachelor's Degree or Master's Degree or PhD in Engineering or equivalent.
• Required skill(s): Aseptic Environment, Grade A cleanroom.
• At least 15-18 years of working experience in the related field is required for this position.
• Preferably Senior Managers specializing in Engineering - Chemical or equivalent.