Catalent Pharma Solutions (a Blackstone Group company) is a leading Drug Development, Advanced Delivery Technology and Supply partner to the global pharmaceutical industry. A Fortune 1000 company, with over 29 locations on 5 continents, we partner with 90 out of the top 100 pharmaceutical companies and 44 of the top 50 biotech firms, as well as thousands of small innovator companies.
I. Position Overview:
We are looking for an experienced QA Professional with a strong and demonstrable history of working in both an R&D and Operational setting to become a Global Quality Lead within Catalent Pharma Solutions.
This is broad role will see the successful candidate work across multiple geographies liaising with both internal and external stakeholders including CRO’s and Bioanalytic testing laboratories.
We would expect the successful candidate to have proven experience in developing, implementing and maintaining QMS Systems, the authoring of technical agreements and both internal and external auditing.
In addition, the Global Quality Lead must have a demonstrated ability to identify, manage, and drive projects to completion utilising innovation and leadership.
For a more a more exhaustive list of duties please see below.
II. Specific Duties, Activities, and Responsibilities:
Maintain a working and practical knowledge base of cGMP’s.
Create a Quality System that is appropriate to the requirements of the Product Ventures Group. Establish objectives, plans, policies and procedures that are compatible with cGMP’s, Corporate Quality policies and standards and other appropriate regulations.
Author Technical/Quality Agreements both intra-Catalent and external to Catalent.
Monitor the status of vendor audits needed in conjunction with Corporate Compliance. Ensure appropriate management and follow-up on the output of such audits. When situations dictate, project support such as a vendor visit or vendor audit (for cause) may be necessary.
Perform gap assessments followed by the development of practical risk assessments.
Develop and maintain sound working relationships with the Catalent facilities supporting PVG projects.
Maintain a working knowledge base of GCP’s while ensuring compliance via clinical monitoring and clinical oversight.
Oversee the process of batch documentation authorship, review, and release for development products.
Ensure that relevant metrics are maintained and reported.
Directly responsible for managing and coordinating the review of technical documents from a Quality Assurance perspective.
Demonstrated competence with compliance review of diversity of Quality documents.
III. Position Requirements:
Education or Equivalent:
Bachelor’s Degree in Science or Engineering
Minimum of 7 years experience in Quality Assurance, Regulatory Affairs, and/or Validation, in a pharmaceutical manufacturing environment or equivalent combination of education and experience
Catalent Pharma Solutions - 10 months ago
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