A brilliant opportunity exists for an outstanding individual capable of fitting in to this very rewarding Director of Quality Assurance role. Our client is looking to hire someone who can bring in additional value to the role; so if you're someone who is dedicated, energetic and can ensure thorough attention to detail at all times, this could be the perfect role for you.
1) Review and report overall quality status
2) Ensure that all systems under QA management are functioning and being followed
3) Oversee QA Department for batch release, document management and training
4) Generate and maintain quality policies and manuals
5) Review and QA approve of all GMP documents such as SOPs, protocols, batch records, deviation, change controls, CAPAs, etc.
6) Oversee Audit Department for customer audits, supplier audits and quality & regulatory audits
7) Generate and maintain the audit master plan
8) Be responsible for generation of quarterly management review and annual product reviews
9) Review and approve changes according to change control procedure
10) Direct investigation of customer complaints
11) Participate and assist in responding to FDA inspections
12) Mentor quality assurance personnel
More questions? Want to know the Salary range? Keep reading.
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceutical industry is strongly preferred
4) Preference will be given to people have recent experience in quality assurance management
Our client provides their employees with support in an environment that promotes growth and success. If you share the same passion, they welcome your application for consideration!
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.