To supervise, execute and monitor the activities within the value stream to ensure reliable and optimal operation of processes, equipment, utility and facility so as to achieve target production levels within the framework of current Good Manufacturing Practice (cGMP), quality, safety, occupational hygiene and environment protection.
Responsibilities
- Co-ordinate with the relevant parties and contribute to the development of the monthly production schedule to enable timely material support to production, and to optimize the production of bulk drug substances so as to minimize holding costs of intermediate goods.
- Assess situation, plan and implement all process campaign turnaround activities, as well as co-ordinate and track progress of shift teams to ensure production plan adherence.
- Identify and implement improvement to plant facilities, processes, methods of operations and turnaround, troubleshoot for process and equipment problems to minimize safety and quality risk as well as to ensure greater operational efficiency.
- Lead or support quality or safety related investigation using appropriate problem solving tool to determine the root causes and implement CAPA to prevent recurrence.
- Initiate, coordinate, plan and participate in plant modification activities, in the implementation of capital projects, project commissioning and tie-in.
- Conducts audits and investigations, participate in audit preparation and complete identified actions in the assigned work area(s), in order to ensure compliance with GMP and safety requirements.
- Prepare documents relating to manufacturing, plant turnaround, Work Instructions (WI), Local Standard Operating Procedures (SOP) and training manual to ensure that updated documents exist to support the activities of the operations department, schedule plan orders, and materials assignment. Documentation should comply to Data Integrity requirements and adherence to ALCOA principles.
- Provide inputs to Periodic Product Review, Computer System Review and Cleaning Validation Review, Engineering Technical Review.
- Support the Production Manager in new product introduction or plant trials and prepare and complete all necessary documents related to plant trial within the stipulated timeline.
- Participate in the qualification works at OQ and PQ phases.
- Provide M-ERP Support as BPE if assigned.
- Raise and coordinate change control implementation and follow up on closure of change control.
- Ensure availability of equipment, tools, production consumables, transfer of input materials as part of campaign preparation and follow up on ensuring housekeeping of above upon campaign ending.
Knowledge, Skills & Responsibilities
- Min degree in Chemistry or Engineering
- Experience in pharmaceutical industry
- Experience in working with GMP
- Knowledge of product, production processes and the plant
- Basic engineering knowledge
- Basic statistical knowledge
- Good troubleshooting skills
- Basic project management skills
- Effective communication skills
- Auditing skills
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Why Us?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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