Product Lead

Site Name:
Pakistan - Sindh - Karachi

Posted Date:
Nov

*Job Purpose*
To 'own' and provide technical leadership for a product or product family at a local (site) and/or global level (across all sites where the product is manufactured) and to ensure that the product is delivered to the highest levels of quality and robustness.

*Education, Experience & Skills*

• Pharm-D or MSc Chemistry
• Demonstrated experience in the Pharmaceutical or FMCG industry in leading the technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, Process Validation, Cleaning Validation and change control.
• At least 3 years of relevant experience

*Key Responsibilities*

• Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s): Technical Risk Assessment, Product Control Strategy (and translation to standard work as batch manufacturing instructions as per the principles of GPS), Continued Process Verification and Process Robustness Assessment. Ensure risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards
• Responsible for assessing the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of AL2/AL3 primary changes impacting API material properties, assessment of impact of API/excipient changes on the dose form, via the Material Risk Assessment process (MRA), process changes, equipment changes etc.
• Coordinates and establishes key relationships within site across Operations, Technical, Quality and Engineering for the product(s) for which he/she is accountable, and above site with other Product Owners.
• Responsible for ensuring and supporting the validation working party in achieving validation targets as per defined timelines. Ensure the Site Validation Master Plans (Process Qualification) and Cleaning Validation Master Plans are in place in compliance with the global GSK standards and local regulatory requirements.
• Define validation/ sampling strategies using statistical tools and approaches, prepare the validation protocols that fulfil current compliance requirements and ensure that validation activities are carried out in consultation with Production, Quality function, Warehouse, Engineering and technical. Prepare and ensure that the Validation Summary Reports with thorough data review, analysis and interpretation to confirm the outcome of validation exercise. Identify and manage deviations from validation plans ensuring effectiveness of validation approach.
• Ensure and coordinate cleaning validation & verification activities are carried out timely with all related documents in place along with the periodic reviews of validated manufacturing and filling processes and cleaning processes to ensure that they remain in validated status.
• Conduct management monitoring/ IBM to ensure compliance with the procedures and systems as per audit universe and timely closure of all actions and CAPAs

*Key Responsibilities*

• Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s): Technical Risk Assessment, Product Control Strategy (and translation to standard work as batch manufacturing instructions as per the principles of GPS), Continued Process Verification and Process Robustness Assessment. Ensure risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards
• Responsible for assessing the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of AL2/AL3 primary changes impacting API material properties, assessment of impact of API/excipient changes on the dose form, via the Material Risk Assessment process (MRA), process changes, equipment changes etc.
• Coordinates and establishes key relationships within site across Operations, Technical, Quality and Engineering for the product(s) for which he/she is accountable, and above site with other Product Owners.
• Responsible for ensuring and supporting the validation working party in achieving validation targets as per defined timelines. Ensure the Site Validation Master Plans (Process Qualification) and Cleaning Validation Master Plans are in place in compliance with the global GSK standards and local regulatory requirements.
• Define validation/ sampling strategies using statistical tools and approaches, prepare the validation protocols that fulfil current compliance requirements and ensure that validation activities are carried out in consultation with Production, Quality function, Warehouse, Engineering and technical. Prepare and ensure that the Validation Summary Reports with thorough data review, analysis and interpretation to confirm the outcome of validation exercise. Identify and manage deviations from validation plans ensuring effectiveness of validation approach.
• Ensure and coordinate cleaning validation & verification activities are carried out timely with all related documents in place along with the periodic reviews of validated manufacturing and filling processes and cleaning processes to ensure that they remain in validated status.
• Conduct management monitoring/ IBM to ensure compliance with the procedures and systems as per audit universe and timely closure of all actions and CAPAs

**Why GSK?

Uniting science, technology and talent to get ahead of disease together.**
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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