Batch Release Specialist
Batch Release Specialist
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Job Description
Position Summary
Are you passionate about ensuring quality and compliance in a fast-paced manufacturing environment As a Batch Release Specialist in the QP Importation Team you will play a key role in preparing product release dossiers for presentation to Qualified Persons (QPs). You will review batch manufacturing and packaging records artwork quality notifications transportation and temperature records sampling plans and test results.
You will escalate issues to manufacturing sites warehouse teams and logistics groups that arise from the reviews to support batch certification processes.
We create a place where people can grow be their best be safe and feel welcome valued and included. We offer a competitive salary an annual bonus based on company performance healthcare and wellbeing programmes pension plan membership and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK GSK
Responsibilities
- Prepare batch release dossiers for presentation to the QP to support compliant batch release.
- Escalate any issues identified: Review associated records and documentation including deviations and liaise with the manufacturing site/External Quality and QP to understand the impact of the deviation on product quality prior to release.
- Raise and track Transport Incident Logs (GTIL) for transit temperature excursions liaising with the Pharma Logistics Operations groups and supplying sites to resolve and close ensuring escalation to the QPs.
- Conduct activities to support QP Importation processes related to quality oversight for importation including quality meetings; investigations and reporting; periodic product reviews.
- Ensure records of batches certified are maintained and dossiers and samples archived in accordance with local SOPs and GMP requirements.
- Communicate effectively with cross-functional teams including Supply Chain Hubs Local Operating Companies manufacturing sites External Supply Quality managers and importation warehouse and provide feedback to all on progress of release as required.
Qualifications/Skills
Basic:
- Degree in a relevant science field (e.g. Pharmacy Chemistry Biology).
- Experienced in manufacturing site operations batch record review quality data review and operational quality requirements.
- Knowledge of GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) regulations.
- Demonstrated experience of Quality assurance/GxP documentation review and management Deviation RCA and CAPA management and/or support.
- Experienced in using IT and electronic documentation and/or Quality management systems such as Microsoft Office Veeva Quality suite Trackwise LIMS MES etc.
Preferred:
- Understanding of quality management principles and documentation requirements (ALCOA) for GMP compliance.
- Capable of working in multi-disciplinary teams across IT Quality External Supply Global Logistics Supply Chain and Manufacturing.
- Working knowledge of GMP and GDP regulations.
- Experienced in application of continuous improvement concepts and knowledge of performance measures.
Closing Date for Applications 07 Sep 2025 (COB)
Please take a copy of the Job Description as this will not be available post closure of the advert.
When applying for this role please use the cover letter of the online application or your CV to describe how you meet the competencies for this role as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
We manufacture and supply reliable high-quality medicines and vaccines to meet patients needs and drive our performance.
Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; its vital to bringing our innovations to patients as quickly efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines enabling us to increase the speed quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products harnessing the power of smart manufacturing technologies including robotics digital solutions and artificial intelligence to deliver for patients.
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 were 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.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.
We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0. The helpline is available from 8.30am to 12.00 noon Monday to Friday during bank holidays these times and days may vary.
Please note should your enquiry not relate to adjustments we will not be able to support you through these channels. However we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Unclear Seniority
Employment Type
Full-Time
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