Job Purpose

To ensure that products released for sale have been manufactured and packed in accordance with the licensing requirements, Quality Management System, Good Pharmaceutical Manufacturing Practice and business requirements, and to promote quality/compliance within their area of operations.
To ensure cGMP practices and quality standards on processes, products personnel and systems ensuring compliance to control procedures and regulations.

Education, Experience & Skills

• B-Pharm/ Pharm-D or M.Sc.

• 5+ years experience

• Computer literacy, minimum to access and utilize emails for official correspondence

• Use of MS-Office (Word, Excel, PowerPoint) at least to a moderate level

• Good communication and presentation skills

Key Responsibilities

In-Process Control (Oversight Lead):
Manage Oversight team to:

• Ensure in-process checking during operations (oversight) are according to SOPs, understanding of core Operational Quality processes and taking action to mitigate risk.

• Ensure that manufacturing, filling and packing activities are performed according to BMR, BPR and relevant SOPs.

• Data Integrity & Compliance: Support in Data integrity implementation and improve the DI controls at site.

• Product Release: Support in compilation and review batch documents and release products to ensure that manufacturing, filling and packaging activities are performed according to BMRs, BPRs and relevant SOPs and ensure that batch dossiers are retained as per local regulatory and GSK record retention policy, if required.

• Site Archive Room, Batch Document Room & Retained Sample Room: Ensure that compliance related documents are retained as per GSK record retention policy and ensure that batch record rooms, storage, archiving and traceability of the documents are managed.

• Deviation Handling: Report deviation and support in rectification of deviations from cGMP or the Quality Management System, providing advice to line management to ensure that cGMP compliance requirements are built into the site's core practices and ensure that product quality issues are correctly investigated, and that appropriate corrective and preventive actions are implemented.

• Investigation Handling: Support in investigations of products failing to meet standards, support and coordinate with stake holders for the CAPA preparation.

• CAPA Plan Handling: Ensure all QMS requirements for Operational Quality including Self inspections, SOP status, Trainings, CAPA closure, Gap analysis actions and others are timely completed and communicated to relevant stake holders.

• Periodic Product Reviews: Ensure that Periodic Product Reviews are carried out as per approved procedure

Customer Complaints (Site Customer Complaints Coordinator):

• Ensure market complaints are handled effectively and timely as per standard procedures.

• Ensure complaints are timely logged, investigated, appropriate CAPAs are implemented and investigation outcomes are shared with stakeholders.

Validations:

• Review Validation Protocols and Reports, BMRs, BPRs, Product Transfer Documents, SOPs and any other documents having impact on product quality for Quality Compliance.

• Support in site validation activities by providing OQ input.

Environment, Health & Safety:

• To ensure that EHS practices are being maintained.

• Implement and follow EHS standards and guidelines in Operational Quality.

• Reporting EHS adverse events.

Work With Zero Accident, Defects & Waste By Committing To Safety Fundamentals:

• To ensure that EHS practices are being maintained.

• Reporting of ZIP, ZAP & ZWP and their timely closures to meet site target.

• Actively participate in safety and health related events and improve the working conditions in order to maintain a safer and healthier environment.

Support OQ Manager (In His/Her Absence):

• Support OQ Manager in compilation of weekly and regional KPI data

• Support OQ Manager in conducting Site Quality Council and related activities

• Support OQ Manager in Projects related to Process Simplification with improved quality

• Support OQ Manager in any other task/project as assigned

• Govern all OQ related activities and teams in absence of OQ Manager as designee

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

Contact information:

You may apply for this position online by selecting the Apply now button.

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