As the Head of Site Quality you will manage the compliance across the bio-pharmaceutical production units, ensuring that all aspects of the handling, manufacturing and distribution of the products comply with the requirements of the Quality Manual and Policies and meet all relevant BPF/GMP regulatory and legislative requirements.
* Ensure that the production and control operations are clearly specified and GMP adopted.
* Ensure that managerial responsibilities are clearly specified and carried out.
* Conduct and communicate the results of risk-assessment for quality related topics and ensure that robust actions are taken to mitigate risks.
* Ensure that sufficient experienced and trained resources are available to provide appropriate quality oversight of production operations such that arrangements are made for the manufacture, supply and use of the correct starting and packaging materials, all necessary controls on intermediate products, and any other in-process controls and validations are carried out, and the finished product is correctly processed and checked, according to the defined procedures.
* Ensure that each lot of drug product complies with its marketing authorisation and any other regulations relevant to the production, control and release of medicinal products.
* Ensure that there is a procedure for self-inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the QA system.
* Ensure that a system is available to manage complaints about marketed products, and to organize products recalls.
* Advise the GQO on worldwide biotechnology policy aspects.
* Provide guidance and technical support for the QA operations at biotech plants.
* Support auditing of biotech plants.
* Perform budget forecasts and ensure the requisite approval, as well as to remain within the approved budget.
* Manage the QA teams in compliance with company policies and standards and provide development opportunities to staff to ensure the expertise within Quality is maintained.
* Support the lean, process based strategy within Tech OPS by ensuring a collaborative approach via an adequate organization and workflows
* Drive the quality culture on site together with all functions to support that quality becomes and remains part of everybody's daily activities
If you are interested in this vacancy you must have the following:
- Experience in Vaccines or Biologics is a MUST.
- Be educated to a Master's Degree level, ideally in Pharmacy, Engineering, Chemistry or any other life science related subject such as biotechnology.
- Have a minimum of 10 experience in Quality Assurance and Quality Control within the pharmaceutical industry.
- Have a fantastic experience of GMP and Regulatory Standards within Pharmaceuticals.
- Previous experience in a fast paced environment.
- Be able to demonstrate excellent communication skills and problem solving ability.
- Be fluent in French and English
Desirable : Experience as QP / Responsible Pharmacist in France
If this role is of interest please send your CV to loic.ruffe@secpharma.com or call +44 207 255 6665 for a confidential conversation.
http://uk.linkedin.com/in/loicruffe
