Our Client is a international group dedicated to the cGMP development and manufacture of APIs, serving exclusively the pharmaceutical industry. With a 50-year track record, our Client offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. Due to tremendous growth and profitability, our Client is looking for an experience Head of Quality Assurance to join their team. This is an exciting opportunity for the right candidate to join a fast paced and challenging environment!
Job Responsibilities:
1) To ensure the company’s Quality System, which includes all IOPs, SOPs and Corporate Operating Procedures (COPs), as well as the cGMP Guidelines are adequately applied within the site.
2) Maintains an open communication with employees concerning EHS including documentation of incidents or issues, posting of studies and ensures 100% of QA staff attend safety meetings to communicate current and planned activities.
3) Ensure all activities at client’s Technology Transfer Centre (TTC) are carried out in compliance with all Federal, State and Local requirements, namely: EPA, OSHA and FDA.
4) Ensures that all members of QA are appropriately trained according to Site Safety IOPs, SOP and COPs.
5) Establish career development plans and training plans for its direct reports, evaluate their performance and provide feedback on at least an annual basis and establish annual objectives for all direct reports when applicable.
6) Review all career development plans and training plans, performance appraisals and objectives with the President – US Operations.
7) Provide training on cGMPs and quality related subjects.
Job Requirements:
1) A minimum of a BS degree in chemistry/science or chemical engineering and a minimum of 5 years of industrial experience in either a pilot plant or a chemical facility that is producing pharmaceutical API’s.
2) The candidate must have a strong and complete understanding of Good Manufacturing Practices (cGMPs) as per ICH Q7A as well as US CFR 21 parts 210-211.
Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-03459.html |