This friendly and quality driven organization manufactures a variety of pharmaceutical products including Paracetamol, Asprin, Ibuprofen, Co-Codamol and Saccharin which are then sold by supermarkets and pharmacies nationwide.
As QA Manager and acting Deputy QPPV you will be responsible for guaranteeing that all company products are generated according to Product Licenses following GMP guidelines and EEC directives, you will be reporting to the Managing Director.
Key Responsibilities:
• Authorize specifications, sampling instructions, test methods, QC procedures and assess production documents and amendments
• Agree or decline starting materials, packaging components, intermediate bulk and finished products and appraise all completed manufacturing documents following directives and marketing authorization
• Act as Qualified Person in approving finished products for release onto the market place
• Retain raw material samples, packaging components, finished products and batch manufacture documentation for one year after expiry according to guidelines
• Observe suppliers of raw materials packaging components, maintain a high standard QC laboratory and equipment and organize the validation of analytical methods
• Recruit qualified QC staff and ensure relevant training is carried out
• Investigate all quality complaints according to written procedures and take action as necessary
• Liaise with Quality Systems Manager, Pharmacovigilance Qualified Person, Medicines Control Agency and the Medicines Inspectorate on relevant topics and issues
• Gain authorization from the MCA for variations and amendments which alter the manufacturing or product licenses
• Carry out a “self inspection” program and create company hygiene procedures
You must be a “Qualified Person” for this opportunity and you will ideally have extensive Quality Assurance industry experience and have worked to both GMP and EEC directives, experience of working with generic tablets would be beneficial. You should be organized, motivated, dedicated and efficient with excellent written and communication skills.
This is an outstanding opportunity within intimate company offering excellent benefits including competitive salaries, a pension scheme, a generous holiday entitlement, health insurance and training opportunities to suit individual needs.
Key Words – Quality Assurance, QA, Qualified Person, QP, Quality Assurance Manager, GMP, Pharmaceutical, Manufacturing, London, Colindale
For further information on the role or company please contact myself, Amie Adams at Paramount Recruitment on 0121 616 3473.
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
