Austin Vita has a fantastic opportunity for an experienced QP to undertake the duties of Qualified Person as specified in Article 51 of Directive 2001/83/EEC. You will have management experience and responsibility for a Quality Management System, and as the environment is Sterile Manufacturing, experience in this area would be ideal as well as having been on a UK MHRA licence.
To ensure compliance with the requirements of Good manufacturing Practice.
Contribute to the company quality assurance functions.
Maintain independence from Operational personnel
To review and evaluate batch records and authorise batch disposition (Annex 16 GMP Regulations).
To ensure that testing is carried out, according to analytical control procedures and EU Pharmacopoeia specifications
To approve process deviations / laboratory investigation ensuring that problems are addressed in compliance with GMP and company procedures.
To monitor the nature, extent and frequency of complaints
To coordinate recall procedure.
To ensure appropriate 'analytical method' validation is carried out for all non compendial test methods.
To support site validation activities ensuring that regulatory requirements are met.
To approve Change Control procedures.
To coordinate internal and external auditing programmes.
To monitor performance of suppliers, contract laboratories and contract manufacturers (where applicable).
to review GMP and GLP training plans prepared for company personnel and contracted service personnel (maintenance and cleaning) as appropriate.
To participate in training and assessment activities related to the position of QP.
You will be rewarded with a fantastic salary and benefits package.
If this sounds of interest, please apply ASAP as my client is currently shortlisting for interview.
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants
Quality Management Systems
Medicines And Healthcare Products Regulatory Agency (Mhra) Guides
Good Manufacturing Practices