QA Facilitator - Systems and Compliance
Summary of role
Setting the Quality Standard for the site, providing site QA support and management of the Systems & Compliance group.
Your Responsibilities
* Ensure that the site quality standards are embedded, measured and sustained in line with Regulatory and Global requirements.
* Preparation and management of the Annual Site Quality Management Plan.
* Providing Overview to site leadership team on the status of the Sterling Pharma Ringaskiddy quality system through Site Quality Governance Board and Annual Quality Management Review.
* Ensure Global and Local QA Projects and Initiatives are resources as required.
* Support Quality Culture and Data Integrity on site.
* Manage and co-ordinate the activities of the Systems & Compliance group to ensure that all Compliance activities are performed with specific regard to the below:
o Management of Inspections by Health Authorities, Customers and Sterling Pharma auditors.
o Ensuring Internal Audit Programme and Supplier Audit Programmes are in place and adhered to.
o Management of Customer Relations including Declarations & Notarizations.
o Management and Quality Oversight of both the complaint handling and the deviation quality system.
o Quality Oversight of Equipment Qualification, Automation, Site Master File, Computer Systems Validation, Facilities. Management & Quality oversight of document management systems.
o Ensure that approved vendors are available for all materials required by production and that all aspects of the vendor management system are adhered to including vendor approval, vendor monitoring and quality agreements.
o Ensure Introductory and refresher GMP Training is provided and fulfils site needs.
o Ensure Quality metrics reporting is completed in a timely manner.
Requirements
* Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
* Desirable: PHD in Science/Engineering (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology, Chemical Engineering) or equivalent.
* At least 8 years’ experience working on a manufacturing site (e.g. QA and/or Production) or equivalent experience from external company or other line function. 4 years’ experience leading a team.
* Fluent English required (oral & written). Good skills in site (local) language required (oral & written).
* Good working knowledge GMP regulations required within the pharmaceutical industry.
* Proven track record of successfully working in interdisciplinary teams and of simultaneously planning, coordinating and/or leading activities on projects.
* Computer literacy (e.g. MS-project, Power Point, document management systems, databases) available and ability to quickly learn new software, tracking tools and associated processes.
* Excellence in influencing people, in negotiation and communication skills as well as potential for excellence in leadership.
* Excellent organizational skills in order to drive projects with a proactive and action-oriented attitude.
Why consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.
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