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- Leading Oncology Generic Pharmaceutical Manufacturer
- North West London
About Our Client
Our client is a leading manufacturer of medication which is growing rapidly and will be the largest supplier of generic pharmaceuticals in Europe by 2017. Due to increased demand, the solid dose, oncology site is expanding and they are now seeking a Qualified Person to join their Technical team.
As the Qualified Person (QP), you will be able to fulfil the requirements of Article 49 of 2001/83/EC in respect of a Qualified Person: Taking responsibility for and on behalf of the company as the holder of a manufacturing authorisation by certifying batches for release, intended for commercial sale. In doing so, the QP must ensure that a product is fit for its intended use, complies with the requirements of the relevant Manufacturing License, the Marketing Authorisation (MA) and does not place patients at risk due to inadequate safety, quality and efficacy.
* To comply with all GMP regulations.
* To comply with all Company policies and procedures
* To carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and others
* To control and maintain your personal training folder
* To follow a code of conduct conducive to a professional environment
* Certification of batches whilst ensuring timely assignation of verdicts
* To ensure the PL and ML licence requirements have been met
* To monitor customer complaint feedback
* To work with the Quality Assurance team to ensure batch documentation review, certification and certificate of analysis generation is carried out in a timely manner
* To assist in carrying out non conformance investigations
* To be visible and available to production to assist in resolving day to day issues
* To maintain a cross company unity in GMP
* To maintain knowledge of current guidelines and GMP's in line with duty for continual professional development
* To carry out internal and external audits in accordance with the annual audit schedule and as required
* To be available and assist with regulatory authority inspections
* To assist in maintaining and developing all aspects of the quality management system.
* To foster excellent communications with suppliers and manage expectations appropriately
* To implement better ways of working that are quality related and cost effective and demonstrate continuous improvement.
* Clear communication to other departments as required to ensure any issues are highlighted and resolved
* Completion of MHRA or other audits to required standard, no critical or major observations.
Adhered to department metrics at all times
The Successful Applicant
We are seeking a time served Qualified Person who has worked in Pharmaceuticals Manufacturing. Experience with solid dose, generic, oncology medication would be highly desirable.
What's on Offer
£75,000 - £85,000 + Excellent Package