Deskripsi Pekerjaan
Join Roche, a global healthcare pioneer, as a Validation Lead in our RDT Pharma Technical Operations team. In this critical role, you'll safeguard our license to operate by ensuring stringent compliance with regulatory standards and quality requirements. You'll spearhead the validation lifecycle for pharmaceutical processes, equipment, and systems, driving excellence in manufacturing quality and patient safety. As a key technical leader, you'll develop robust validation strategies, lead cross-functional teams, and maintain alignment with evolving regulatory landscapes. This position offers the opportunity to shape quality standards while advancing your career in a dynamic, innovation-driven environment where your expertise directly impacts life-saving medicines.
Tanggung Jawab
- Lead end-to-end validation lifecycle for pharmaceutical processes, equipment, and computerized systems
- Develop and execute validation master plans aligned with GMP, FDA, and EMA requirements
- Manage validation project portfolios, including resource allocation and risk assessment
- Collaborate with engineering, quality, and manufacturing teams to implement validation strategies
- Review and approve validation protocols, reports, and change controls
- Drive continuous improvement in validation methodologies and documentation systems
- Ensure compliance with internal SOPs and external regulatory audits
Kualifikasi
- Bachelor's degree in Engineering, Pharmacy, Life Sciences, or related field
- Minimum 8 years of pharmaceutical validation experience with 3+ years in leadership
- Expertise in GMP, FDA, EMA, and ICH guidelines
- Strong project management skills with PMP certification preferred
- Experience with validation of pharmaceutical equipment and MES/LIMS systems
- Proven ability to lead cross-functional technical teams
- Excellent analytical and problem-solving capabilities