Job Purpose
To ensure the effective implementation and maintenance of quality systems, processes, and procedures across GSK's operations, aligning with regulatory requirements and company standards. This job purpose outlines the key responsibilities, requirements, and KPIs for the Operation Quality Assistant Manager role at GSK.
Education, Experience & Skills
B-Pharm/ Pharm-D/ M.Sc.
5+ years’ experience
Computer literacy, minimum to access and utilize emails for official correspondence.
Use of MS-Office (Word, Excel, PowerPoint)
Good Communication and presentation skills.
Key Responsibilities
To ensure that products 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.
Ensure in process control checking during operations are according to Standard operating procedure.
Ensure end to end production process from material issuance, dispensing, manufacturing, filling, and packing activities are performed according to Batch manufacturing and packaging instructions.
Ensure sampling and delivery of testing samples as per sample plan.
Ensure that documents are retained as per GSK record retention policy.
Ensure Finish good retention sample management storage and destruction as per Standard operating procedure.
Ensure Data integrity practices and improve the DI controls at shop floor.
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.
Support in customer complain investigations of products and coordinate with stake holders for the CAPA preparation.
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.
To support department in providing improvement solutions with respect to job role to make the operational quality processes more robust.
Coordinate with team in identifying the risk in processes and manage its mitigation/elimination by taking relevant actions.
Validations
Review Validation Protocols and Reports, BMRs, BPRs, and any other documents having impact on product quality for quality Compliance.
Support in site validation activities by providing OQ input.
Environment, Health and Safety
Ensure continuous improvement in EHS performance and ways of working.
Reporting EHS adverse events and ensure their closures by using standard procedures.
Implement and follow EHS standards and guidelines in Operational Quality.
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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