Based in Borehamwood/Elstree, Hertfordshire, we have an exciting opportunity to join our QA team as an Qualified Person within an organisation that provides a continuous supply of reliable, high quality plasma-derived products worldwide, supporting both healthcare professionals and patients every day.
As an Qualified Person in QA, Quality you will contribute to the Quality Laboratory function at BPL, through competently taking and testing samples in accordance with departmental Standard Operating Procedures, BPL Policies, and to the principles of GMP.
Hours of work – Monday to Friday, 9am to 5pm.
Key Duties & Responsibilities:
1. You will be named as the Qualified Person on the MIA and will ensure that all products are manufactured and released in accordance with EU directive 2001/83/EC.
2. As the Qualified Person, you will be responsible for ensuring the site wide compliance against regulatory standards such as GMP. You will have full over site of the companies Quality Systems, QMS, and will manage CAPAs, Deviations, Change Controls etc.
3. As a Qualified Person, you will also work closely with the wider Quality Assurance function, providing support where applicable. Highlight significant GMP failures or any other concerns relating to product quality, safety, efficacy or compliance to senior management, including the Head of QA. Attend the quality governance meetings as directed and required.
4. Ensure that complaints, deviations, adverse events and any other significant quality incidents are thoroughly reviewed and closed out in a timely manner. Contribute to the review performance of the company quality systems. Work as part of the team to undertake continuous improvement of business quality systems
1. You will be degree qualified within a Scientific related discipline and recognised as a Qualified Person. The company offer a training and support function for their QPs and as such, no specific product release experience is necessary. However, a background in releasing sterile products is preferred.
2. Experience managing a Quality System within a pharmaceutical or life science business to regulatory standards.
3. Demonstrated experience in deviation and incident investigation, as well as leading EU and US competent authority inspections. You will also have the capability in leading GMP improvement programs.
In return we offer:
- Competitive salary
- Bonus scheme
- Life Insurance
- On-site parking
• Subsided canteen
• 25 days annual leave
Please note that this role is being managed by an external Recruitment & Talent Organisation, Hyper Recruitment Solutions (HRS), who will be managing this vacancy on behalf of BPL. By submitting your application, your details will be shared with the HRS team