Quality Assurance Lead

Quality Assurance Lead

Corsham, Wiltshire

Permanent – 37.5 hours per week

“Do you want to work for an organisation that makes life-changing pharmaceuticals?  If yes then read on…”

Our client is recruiting a Quality Assurance Lead to join their friendly, dynamic team in the development of their capacity and capability to deliver their products to hospitals and patients homes across the UK and beyond.

They are looking for someone that is passionate about making a difference to patient lives, dedicated to improving company processes, has a drive to be an expert in what they do, wants to be part of their fantastic company community and is as committed to their career training and progression as the company is. Do you have the qualities that they are looking for?

You will have a range of key primary and secondary duties to include:

• Maintain an overview of all aspects of the Pharmaceutical Quality System (PQS) to ensure its suitability and effectiveness and ensure non-compliance issues are addressed.
• As part of the Quality Assurance Team you will be accountable for up to 5 Key Quality Process such as:

CAPA, Recall, Regulatory Updates, Complaints, Deviations, Change Control, Trends, Environmental Monitoring, Supplier Assurance, Stability, Documentation, Quality Metrics, Audit & Inspection, Quality Risk Management, Data Integrity and Validation.

• Produce regular reports detailing the status of the PQS for dissemination to the Head of Quality, QA Manager, Production Management, Managing Director and Audit/Risk Committee.
• Escalation of issues to the Head of Quality/ QA Manager.
• Generation and GMP approval of key documentation within the PQS.
• Conduct internal audits of the PQS as per the defined audit schedule.
• Assist with periodic Regulatory GMP/ GDP Inspections and site preparation.
• Lead and assist internal audits and inspections by clients.
• Lead or support gap analysis, risk assessments and risk management activities.
• Drive the timely implementation of risk-based changes and manage quality led improvement projects.
• Lead investigations to determine root cause and identify effective CAPA.
• Ensure that SOPs are complied with and processes and procedures kept current.
• Maintain awareness of changes to quality regulations and guidelines, participating in the assessment of any business implications of these changes.
• Identify and deliver training on GxP topics and Quality Management System processes.

The successful candidate should have a BSc (or equivalent) in a Science based subject and be a member or eligible for membership of either the Royal Society of Chemistry/ Biology or Royal Pharmaceutical Society of GB.  You should have previous experience in a QA role and have clear knowledge and awareness of the principles of QA. Specific understanding of GMP and GCP with previous experience of auditing processes would be desirable.

Benefits

In return they offer rewards and benefits including:

• Salary of £30,00 - £37,500 per annum (dependent on experience, knowledge & skills)
• 29 days holiday, inclusive of bank holidays. Increasing with service
• Generous Pension scheme
• Life Assurance
• Company bonus scheme
• Additional non-contractual benefits including free breakfast and outdoor gym

Nestled in the heart of the West Country with easy access to the World Heritage City of Bath, and with great transport links to London you can experience an unparalleled quality of life in a company that also has a zero-carbon status.

About the company

Our client is a Group which operates within the pharmaceutical aseptic compounding, clinical homecare and laboratory services sectors.  The Group now includes over 320 people with a leading-edge turnover greater than £190 million.

They have invested in a new, multi-million pound manufacturing facility and offices in Corsham, Wiltshire – offering an unrivalled opportunity in a successful and expanding company with a great team spirit.

How to apply

If you would like to apply for this position, please do so with a covering letter and CV expressing what experience, knowledge and skills you could bring to this role.

Closing date for completed applications is 29^th November 2019. You will be contacted by 2^nd December 2019 if you have been shortlisted for an interview and these will take place 10^th December 2019.

*PLEASE NOTE – by applying to this position, you agree for your CV to be submitted to our client, who shall contact you directly, should your application make their short-list.  You also agree to our Privacy Policy: acapella-recruitment.co.uk./privacy-policy.html which can be found on our website.