Company: Optimus Search Limited
Closing Date: 14 Dec 16
Type: Full Time
Salary (£): 100,000+
Optimus Life Sciences is working with a global Pharmaceutical Client to find a QA Lead Manager. The incumbent is responsible for all aspects of Quality assurance across the site including existing commercial operations, technical transfers and new technology platforms
QA Lead Manager (QP) – Germany, Baden-Württemberg - up to €150,000p/a
Optimus Life Sciences is working with a global Pharmaceutical Client to find a QA Lead Manager. The incumbent is responsible for all aspects of Quality assurance across the site including existing commercial operations, technical transfers and new technology platforms. This role has a primary role in assuring that products manufactured at the site are done so in accordance with cGMPs and pertinent corporate and regulatory requirements, in addition to ensuring support for local and global batch release.
Widely known and respected, our QPs have experience across a wide range of product types and dosage forms. We also have an experienced support team who are able to assist you in the release of IMPs for use in clinical trials, including importation into the EU when necessary.
To provide independent QA/QP oversight of all operations
To ensure that appropriate quality standards and systems are in place, and applied across the site operations in accordance with regulatory and global requirements.
Provide quality expertise and oversight of cGMP activities across the site.
Ensure operations and support departments are in compliance with cGMP.
Manage QA team through QA Managers to provide quality and compliance support for the site.
Ensure Qualified Person support for site and global batch release.
Ensure preparation and support for regulatory and external inspections.
Work collaboratively with support departments while ensuring high cGMP standards.
Ensure effective stakeholder management for corporate support departments, bulk drug substance manufacturing sites and associated sister sites.
Be an effective and engaged member of the broader Quality Leadership and Extended Leadership teams to manage the day to day business ensuring supply to patience and protection of our right to manufacture medicines.
Degree in Science or related area (Chemistry, Biochemistry, Biotechnology, Microbiology or Pharmacy preferred).
Wide ranging technical knowledge and experience within the pharmaceutical industry.
Substantial industry experience in a site producing sterile pharmaceutical products under EU and US standards including quality management experience.
A proactive approach which builds Quality & Compliance into processes.
Experience in cementing teams, and delivering outstanding effectiveness from those teams.
Post-graduate studies as appropriate to augment primary degree – MBA advantageous.
Qualified Person status
If you are interested, please get in touch with:
Rob Chaplin, Optimus Life Sciences, +44 (0) 203 418 8033.
171-177 Great Portland Street, London
|Tel:||+44 (0) 20 3418 8033|
|Fax:||+44 (0) 20 7287 4908|
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