Validation Lead - Raleigh, United States - EPM Scientific

Description

Validation Lead

Location:
Raleigh, NC

Working Situation:
Onsite

Position Overview:

Our client is a global pharmaceutical company 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.

Responsibilities:

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.

Qualifications:
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.
If you are interested in the role of Validation Lead, don't hesitate to apply today

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