Validation Expert Lead
7 days ago
We are seeking a highly skilled and experienced QA Validation Lead to join our team at SK pharmteco.
About UsAs a global Contract Development and Manufacturing Organisation (CDMO), we have state-of-the-art facilities in Korea, US, France, and Ireland. Our mission is to produce and deliver life-changing therapies that improve patient outcomes and save lives.
Current NeedThe successful candidate will be responsible for qualification of computer systems, familiarity with ALCOA+ Data Integrity and Compliance Assurance, assessment of changes for GMP compliance, laboratory equipment validation, and review and approval of GMP design aspects of major capital projects.
Key Responsibilities- Lead the qualification of computer systems ensuring compliance with current industry regulations, guidelines, and trends.
- Develop and implement strategies for data integrity and compliance assurance.
- Assess changes for GMP compliance and ensure all quality systems are implemented/executed in compliance with ICH Q7, EudraLex, 21 CFR and site Quality standards.
- Provide expertise in validation ensuring compliance with current industry regulations, guidelines, and trends.
- BSc/BEng in Computer application/Engineering or a science-related discipline with at least 4-5 years pharmaceutical experience ideally in a CSV role.
- Proven leadership skills with experience leading projects with a small team (1-2 people).
- Experience in change control/documentation management, good manufacturing practices.
- Strong interpersonal, communication, and presentation skills.
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Technical Validation Expert
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Dublin, Dublin City, Ireland CPL Full timeJob Overview:CPL in partnership with our client Pfizer seek a skilled Cleaning Validation Specialist to join their team for an 11-month fixed-term contract at their state-of-the-art plant in Dublin. The ideal candidate will provide technical support for cleaning validation activities, ensuring compliance with regulatory requirements and company manufacturing...
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