- Location: Raleigh, NC
- Working Situation: Onsite
- Develop and implement comprehensive validation strategies for sterile manufacturing processes, equipment, and systems to ensure compliance with regulatory requirements (e.g., FDA, EMA, etc.) and industry standards.
- Lead the creation, review, and approval of validation protocols and reports, including but not limited to process validation, equipment qualification, cleaning validation, and computer system validation.
- Collaborate closely with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory Affairs, Engineering, and R&D, to resolve all GxP related issues effectively including discrepancy investigations, CAPAs, change controls, key process development activities, and continuous improvement process reports.
- Oversight of all GMP Compliance and Operational QA (Quality Assurance) aspects of Product.
- Provides insight into the creation, revision, review, and approval of validation protocols.
- Bachelor's degree in a Science, Engineering or related field
- Minimum 5 years of experience in validation within the pharmaceutical industry, with specific expertise in sterile manufacturing processes and regulatory requirements.
- Experience necessary with pharmaceutical process validation, cleaning validation, equipment, utilities, and computer system qualification processes.
- Ability to work independently and as part of a team.
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Validation Lead - Raleigh, United States - EPM Scientific
Description
Validation Lead
A global speciality pharmaceutical company is looking to bring on a Validation Lead to support the global quality organization. You will be supporting tech transfer and validation activities while also working cross-functionally to support all GxP related issues at the Raleigh, NC site.
The Validation Lead will be responsible for:
The Validation Lead will have the following qualifications:
If you are interested in the role of Validation Lead, don't hesitate to apply today
