Job Title: Quality Specialist
Rate: Competitive in line with skills / experience
Type: Contract
My client a specialist pharmaceutical manufacturing organization urgently seeks a talented
Quality Specialist
to join its site Quality team. This role plays a key part in ensuring production is achieved
right first time
, while maintaining full compliance with GMP and internal quality systems
Key Responsibilities
* Acting as a quality representative within cross-functional teams to support right-first-time production.
* Reviewing and approving batch, cleaning and laboratory testing documentation.
* Ensuring laboratory OOS results and process deviations are documented, assessed and supported with appropriate CAPAs.
* Supporting deviation investigations, process performance monitoring and trend analysis to identify improvement opportunities.
* Providing expert knowledge of site quality systems, ensuring effective root cause analysis and completion of corrective actions.
* Advising on quality requirements to maintain validation status, including participation in process and product risk assessments.
* Driving continuous improvement by identifying and addressing recurring quality issues.
* Managing change controls to ensure they are properly documented, assessed and closed.
* Preparing Annual Product, Process and System Reviews.
Required Experience & Skills
* A degree or postgraduate qualification in Science, Pharmacy or a related discipline.
* Strong knowledge of GMP requirements, including experience in electronic or paper-free quality systems.
* Experience with Quality IT systems (e.g. SAP, TrackWise or similar) is desirable.
* Demonstrated experience in Lean methodologies or Continuous Improvement initiatives.
* Experience in high-potency manufacturing environments is an advantage.
* Excellent written and verbal communication skills, with the ability to present information clearly and effectively.
Interested? Apply now for immediate consideration or contact Michael Owusu-Ansah on – mowusu--
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