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Site Name: Pakistan - Sindh - Karachi
Posted Date: Apr 1 2020

Job Purpose

Lead the site Technical with responsibility for all Technical aspects of the Product Lifecycle on site, and a focus on performance, delivery, capability, behavioural development and talent management to enable the site to meet its business goals.

Minimum Level of Education

Pharmacy Degree

Preferred Level of Education

Masters/ PhD or equivalent in appropriate Pharmaceutical.

Experience & Skills Required

• 5-8+ Years of Experience of working in Pharma Manufacturing
• 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
• Thorough knowledge of GMP and Regulatory requirements
• Ability to use and interpret data to drive decision making at both tactical and strategic level
• Detailed understanding of Quality by Design and risk management approaches, including FMEA, RCA and technical risks assessments
• In depth understanding of pharmaceutical/product development
• Thorough operational knowledge of manufacturing unit operations and plant/laboratory equipment
• Experience in Operational Excellence tools, and use of process performance metrics

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.
• Technical leadership to support product control strategy translation to shop floor (batch instructions, standard work etc), utilising 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 GMS technical community for timely resolution.
• Accountable for on time and right first time delivery of technical aspects of NPI, Tech Transfers and Value Engineering projects
• Responsible for dose form platform ownership and new technology industrialization (with Engineering)
• Delivery of key process improvement/optimization projects that contribute to key site metrics; Cost of Goods, Process Robustness, Cost of Poor Quality, yield, BNRFT and waste- process and testing to improve competitiveness and support the commercial ambition.
• Development of business growth opportunities by establishing strong links with Commercial, Category & R&D teams and assuring Technical considerations are a core component of network and category strategies.
• Proactive Talent Management, including succession planning and capability build within the Technical team and active support of the GMS graduate programme.
• Responsible for knowledge management of products throughout their lifecycle
• Ensure that Site Safety and Quality Compliance are championed as part of Leadership team
• Responsible for raw material and packaging material changes
• Liaise with regulatory department to support products files preparations, documentations and on time submission.

Contact information:
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