Senior Quality Systems Officer

Full Time Permanent

A day in the life of a Senior Quality Systems Officer

As a Senior Quality Systems Officer at Wockhardt, you will be responsible for maintaining and improving the site PQS in line with company, corporate and international standards to support cGMP/GDP compliance and to meet business expectations.

You will be responsible for leading the continuous improvement of site quality systems, such as Quality Assurance Agreements, Annual Product Reviews, Planned Change, Deviations, CAPA, Complaints and Self-Inspection Schedule through monitoring the level of site wide compliance and effectiveness of the site PQS. The role requires the application of ICH Q9 (risk management), focussed initiatives, delivery of training, and maintenance of GMP operating procedures and documentation.

The role will include primary responsibility for the preparation of Quality Assurance Agreements, Self-Inspection Schedule and Annual Product Reviews together with any other reports and reviews necessary within the quality management system, which will require liaison with Clients and vendors to ensure all documentation is completed as defined by cGMP/GDP. You will provide support for other site projects, from a Quality Assurance perspective, by reviewing and approving where appropriate, project documentation including risk assessments, ensuring compliance with cGMP/GDP, company and other regulatory agency requirements.

What we’re looking for:

You will have substantial experience within the pharmaceutical Quality Assurance environment, with strong experience of Self-Inspections, liaising with clients in relation to application and generation of Quality Assurance Agreements and completing Product Quality Reviews. You will have a thorough understanding of cGMP/GDP and its relationship with Quality Assurance Agreements, Self-Inspections and Annual Product Quality Reviews and other current best practices for the Pharmaceutical Quality System, and also the ability to work with concepts and practices often outside the original area of academic qualification.

You will ideally have a degree (or equivalent) in a scientific discipline, membership of a recognised professional body (e.g. RSC) would be an advantage. Other key skills are a keen eye for detail, an inquisitive, analytical mindset, with effective written and verbal communication skills and the ability to use computer software systems, including SAP or equivalent and Microsoft Packages (including Excel). You will have excellent interpersonal skills with the ability to take on a supervisory role.

Wockhardt has a range of benefits on offer for all employees including:

* Pension scheme – 7% matched contribution

* Rewards platform – discounts on shopping, restaurants, holidays and more

* Generous holiday allowance

* Salary sacrifice schemes

* Sports and Social club

* Subsidised canteen

* Free parking

You will be working from our Wrexham based site which is home to our MHRA approved sterile injectable manufacturing facility.

Wockhardt UK has been awarded the Investors in People Silver award and a Silver award from Corporate Health Standards for promoting the health and well-being of our employees. A strong family feel, dedicated charity fundraising, fantastic potential for personal growth, and a competitive benefits package make us a great place to work, so what are you waiting for apply now


Looking for more jobs listings visit our website Bird Online Jobs  Search over 200,000 live job vacancies updated daily. Get noticed by over 10,000+ potential employers upload your CV to our partner site here