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 or M.Sc.
- 3+ 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 promote quality/compliance within their area of operations.
- Ensure in process control checking during operations 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 sampling plan and ensure that documents are retained as per GSK record retention policy and ensure Finish good retention sample management storage and destruction as per Standard operating procedure.
- Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues and be responsible for key decision making across activities such as the initial impact assessment for deviations. Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects
- Ensure adherence to frequency of oversight mandated on Critical activities, records and data and GMP Exceptions as defined by risk assessment strategy or procedures for activities such as the review of CPP/CQAs, critical GMP alarms and audit trails
- Monitor and carry out review of documentation and records ensuring that the content meets defined criteria, exceptions have been appropriately addressed, and Good Documentation Practice (GDP) is being maintained following ALCOA+ principles for data integrity, audit and traceability
- Check that both Equipment Cleaning and Preventative & Corrective Maintenance is being performed adequately in compliance with the applicable standards to maintain a controlled environment that prevents any contamination or cross contamination risks
- Ensure housekeeping standards are being followed, facilities are being maintained in a good state and any deviation from the standards are being escalated with associated remedial actions are addressed in a timely manner
- Role model the GPS standards and foster a Quality Starts with Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety
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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