Technical Lead

Job Description

Job PurposeProvide leadership, technical expertise and support for the new products introduction at site through product transfers from sister sites, 3rd party contract manufacturer or developed branded generics to ensure that new products are manufactured site on time and in full. Additionally, act as Site Risk Management Process Owner to implement risk management process so that risks related to EHSS (environment, health, safety and sustainability), Quality, Business Supply and Reputation are identified, analyzed and mitigated to reduce the risk exposure to an acceptable level. And CCM plan owner with sponsorship of site director to cater implementation of crisis and continuity management framework.Education, Experience & Skills

• Bachelor?s degree in Molecular Sciences Pharmacy, Chemistry, D-Pharm or M-Phil
• 7+ years of experience work experience & knowledge of GMP and Regulatory requirements
• Proven capabilities in enabling and driving change, delivering solutions, developing people and building relationships across multiple interfaces and in a matrix environment
• Excellent organizational skills with demonstrated Project Management skills and experience, particularly on major technical and/or capital projects

Key Responsibilities

• Ownership of the core technical business processes for site: Product Lifecycle Management (Technical Risk Assessment, Product Control Strategies, Continued Process Verification, Process Robustness Assessment), New Product Introduction and Technical Transfer to other GMS sites/third party manufacturers, Change Control and Risk Management.
• Matrix leadership across Technical, Engineering, Operations, Quality, Packaging & Logistics to support product control strategy translation to shop floor (batch instructions, standard work etc), utilizing the principles of the GSK Production System (GPS).
• Technical governance across Product Lifecycle; Product Performance at Site, Regional and GMS Quality Councils, Technical Review Board, Product Technical Review Team, Capital Expenditure, EHS, Site Impact Assessment and Change Control.
• Provide technical leadership for the rapid resolution of technical issues impacting supply through and product performance investigations through use of root cause analysis (RCA) tools and appropriate Corrective and Preventative Actions (CAPA) and escalate key site technical issues to the wider community for timely resolution.
• Prepare, monitor & control new products introduction plans to ensure that the products are launched on time.
• Provide efficient, effective and compliant technical support to the Product Stream manufacturing processes and activities in alignment with technical groups based within the Product Stream, and coordinate technical activities
• Delivery of key process improvement/optimization projects that contribute to key site metrics; Cost of Goods, Process Robustness, Cost of Poor Quality, yield and waste- process and testing to improve competitiveness and support the commercial ambition.
• Ensure day to day technical issues are resolved urgently to minimize reject/waste levels
• Responsible for acquiring and maintaining product knowledge expertise, and knowledge management of products throughout lifecycle
• Responsible for ensuring appropriate systems to track, trend and analyse product performance are in place
• Responsible for applying product performance targets to products post launch
• Responsible for the technical aspects of new product introduction to hand over to production
• Ensure governance is in place to for risk management process to ensure business risks are timely identified and managed
• Manage technical risk assessment (TRA) activities to ensure that critical to quality attributes (CQA) in the process are identified and managed during manufacturing
• Support in root cause analysis (RCA) activity for product or process failures to ensure that correct corrective and preventive actions are taken
• Develop and implement plans for improving people and process capability to ensure process robustness and improve site technical capability
• As RMPO, work with business areas to ensure risks are identified, analyzed, evaluated and controlled
• Ensure all required risks are recorded and maintained in RMS & manage access to the site/business area risk register in RMS
• Run RMS Process Review and Summary chart for use at the RMCB meetings, coordinate meeting materials and record meeting minutes
• Provide high level VQMS technical support to local users, support Risk Owners to escalate and cascade risks as necessary
• Ensure routine governance of Site Risk Management System, conduct RMCB every month, ensure presence in Regional RMCB for sharing or escalation of key risks, develop capability of risk reps to facilitate the process of risk identification, evaluation, mitigation and closure effectiveness.
• Ensure robust plans are developed and used for Crisis Management and Business Continuity

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 organisation 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We?re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.Contact information:You may apply for this position online by selecting the Apply now button.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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