QA Officer

QA Officer

PCI Pharma Services

Tredegar, United Kingdom

The role

The responsibility for this role is to assist the Quality Management Team in ensuring that all activities on the Tredegar and Oakdale sites are in compliance with the current Good Manufacturing Practise standards in accordance with company policies to meet business requirements.

This role is based fully on our site in Tredegar and involves a shift pattern with three shifts.

Main responsibilities

• Oversight of Operations including Manufacturing, Primary and Secondary Packaging and Clinical labelling
• To ensure the timely release of product by the review of the critical process parameters of the batch documentation to assess the quality, safety and efficacy of the products prior to Qualified Person certification, in accordance with agreed schedules and Service Level Agreements.
• To perform process and departmental audits against the relevant GMP standards to ensure continued compliance and improvement of systems and processes.
• The job holder is responsible for the interpretation of GMPs for all manufacturing and packaging areas, including development and distribution stages with support from the Head of Quality and site QP’s.
• To perform batch documentation review (preferably in real time) of the critical process parameters of manufacturing, packaging and distribution operations to ensure compliance with written specifications, SOPs, GMP and GDP.
• To perform online batch review for packaging operations as guided by Quality Management to ensure compliance with written specification, SOPs, GMP and GDP.
• To support the review of corrections and training of operations team to reduce the reduction is Batch Record corrections.
• To ensure that following QA review that the batch is suitable for progression to the QP.
• Respond to client requests and batch comments in a timely manner and measure/act on these metrics.
• Complete Finished Product Inspections where applicable.
• Timely completion of tasks in line with business objectives
• To comply with company policies including internal and external Health and Safety and Environmental standards as required.

Qualifications

• A degree in a scientific subject as a minimum (preferably Chemistry).
• GMP Skill Level 1 is desirable for this role.
• Previous laboratory experience is desirable.
• Self-motivated.
• Good communication skills.
• Honest and trustworthy.
• Proven ability and desire to continuously improve, by seeking new approaches and generating ideas.
• Strong time management skills.
• Team Player.
• Organised.

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