QA Facilitator – Systems and Compliance
Summary of role
Setting the standard and ensuring compliance in the areas of Sterling Pharma Ringaskiddy’s Auditing Programs including:
* Internal Audit/ Self Inspection
* Supplier Audits
* Customer Audits
* Health Authority & Corporate Audits
* Act as designee for the Supplier Relations role
* Additional duties include involvement in QA related projects as required
Your Responsibilities
* Management of the Sterling Pharma Ringaskiddy Internal Audit/Self Inspection Programme, including training of internal auditors, preparation of the annual internal audit schedule and monitoring adherence.
* Qualify as an external auditor to support audits of Sterling Pharma suppliers and service providers.
* Lead Sterling Pharma Ringaskiddy audit preparation activities for regulatory and customer inspections
* Co-ordinate Sterling Pharma Ringaskiddy responses to regulatory and customer inspections in conjunction with cross functional subject matter experts (SME’s)
* Perform compliance gap analyses for Sterling Pharma Ringaskiddy site against observations received in other Sterling sites.
* Develop and deliver in-house audit training programs and coach on-site auditors
* Co-ordinate customer quality related document requests i.e. GMP certificates, declarations etc.
* Maintain Site Master File
* Act as designee for the Supplier Relations role.
* Participate in internal / supplier audits and ensure timely close out of actions and responses
Requirements
* Degree in Science (e.g., Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
* Minimum 3 years’ experience working in the pharmaceutical industry in a Quality Role or a Production Role.
* 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.
* Experienced in influencing people, negotiation, and communication skills.
* Excellent organizational skills to drive projects with a proactive and action-oriented attitude.
* Skilled at identifying and resolving areas of concern in relation to quality.
* Good working knowledge of GMP regulations required within the pharmaceutical industry. Be able to impart this regulatory knowledge to site at all levels.
* Proven record of accomplishment of successfully working in interdisciplinary teams and of simultaneously planning, coordinating and/or leading activities on projects.
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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