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Gmp manufacturing specialist/project lead

Milton (G82 2)
SRG
Manufacturing
Posted: 17 April
Offer description

About our client


Our client are an exciting global name in the pharmaceutical industry. This role sits within their GMP production team and is accountable for the oversight of batches manufactured in cleanrooms, supporting the delivery of manufacturing projects to agreed timelines, quality standards and budgets.


The opportunity

As Project Lead in this team, you’ll work closely with client representatives and internal stakeholders to generate batch manufacturing documentation, oversee project execution on the shopfloor, and drive timely completion of records for QA review. You’ll also help guide and develop the wider production team to ensure continuous improvement and successful project outcomes.


Key responsibilities

* Write and review batch records (including PSTs and client batches) following standard procedures.
* Attend client calls and collaborate with Project Management to meet project milestones.
* Understand validation requirements and current status for assigned batches.
* Lead pre- and post-manufacture meetings, ensuring robust preparation and close-out.
* Generate batch-specific KPI data and maintain adherence to reporting timelines.
* Act as DMS SOP author; support investigations (TWD), RCA and CAPA proposals (with supervision).
* Perform basic Oracle ERP functions (e.g., Item Master maintenance; material co-ordination; WIP, yield and consumption reporting).
* Partner cross-functionally to prepare and execute BMR documentation.
* Champion safety awareness and safe working practices; participate in self-development and training of others.


About you

* Degree (or equivalent) in a scientific discipline.
* Experience in a cGMP pharmaceutical manufacturing environment.
* Quality-focused with strong attention to detail and problem-solving skills.
* Excellent time management; able to prioritise and multitask effectively.
* Proficient with MS Word, Excel and Oracle ERP; strong communication and teamwork skills.
* Demonstrates integrity, respect and organisational values; thrives under pressure with multiple priorities.
* Shows sound judgement, motivation and persistence to overcome obstacles while self-managing workload and timelines.


Ways of working & additional information

You’ll collaborate closely with your manager, production peers and cross-functional teams to deliver high-quality products, and maintain regular communication with clients via progress calls and meetings. Occasional out-of-hours work may be required to meet client/production timelines.

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