About Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity:
PQS: Involvement in the development, improvement and control of GxP validation activities. QA Final approval compliance governance function. Reviewing and approving validation documentation, e.g. User Requirement Specifications, Validation Plans, OQ, PQ, Validation Protocols/ Reports, Qualification Data etc.
PQS: Ensuring compliance with AICL(KP) procedures and regulatory requirements.
Participation in project teams to advise and assist in ensuring that validation documentation is written and executed in accordance with internal validation procedures, policies and adheres to the principles of cGxP.
Familiarisation with developments, evolving regulatory requirements and innovations in validation requirements.
PQS: QA Management of site GxP change control processes, ensuring maintenance of GxP compliance, procedural compliance and of the validated state.
PQS: QA Management of Computerised System Periodic Reviews to ensure maintenance of the validated state.
Generation of the site Product Quality Reviews for GxP change control activities.
Biannual Trend Review of GxP site change controls.
Key Responsibilities:
- Validation Standards
- Assessment of current practices to ensure compliance with GMP requirements.
- Familiarisation with developments and innovations in validation requirements.
- Review procedures, reports, results etc. for compliance.
- Validation Documentation and Change control
- Review and approval of validation documents e.g. User Requirement specification, Validation Plans, OQ, PQ, Validation reports etc.
- Review and approval of change controls.
- Review and approval of routine validations.
- Preparation of Periodic review reports.
- General
- Participation in project teams to advise and assist in ensuring that validation documentation is written and executed in accordance with internal validation procedures and policies and adheres to the principles of GMP.
- Biannual Trend Review of GxP site change controls.
Education:
- BSc or equivalent academic qualifications.
Preferred Knowledge Skills & Experience:
- Regulatory requirements for Validation: including Aseptic processing, computerised systems, manufacturing processes, equipment and QC Testing. Industrial/pharmaceutical experience would be an advantage.
Additional Information:
- The position is based in Killorglin. Primarily an on-site role.
- Part-Time: 0.6 FTE (3 set working days: Wednesday, Thursday, Friday).
- This is a 6 month FTC
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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