What are the responsibilities and job description for the Process Validation Specialist position at TekOne IT Services Pvt. Ltd.?
Title: - Process Validation Specialist
Duration: - 12-month renewable contract
Location: - Manchester, NH on (W2Contract)
Responsibilities
Duration: - 12-month renewable contract
Location: - Manchester, NH on (W2Contract)
Responsibilities
- Support the writing of protocols that will be released to both the manufacturing and operations teams.
- Assist with report writing to ensure the deliverables meet client expectations for specific projects.
- Help with running batch record reviews, ensuring thoroughness and compliance with standards.
- Review data protocols to confirm they are both accurate and logically sound, aligning with regulatory requirements.
- Have experience working within fill/finish processes, which is crucial for this role.
- Possess Process Validation experience, which is integral to ensuring product quality and compliance.
- Preferably have previous experience working in a Contract Development and Manufacturing Organization (CDMO), which is highly beneficial for this position.
- Be comfortable in a client-facing, customer-driven role, demonstrating strong communication skills.
- Hold a Bachelor of Science in Biochemistry, Biology, or another relevant life science field, along with 7-10 years of experience.
- Have prior experience specifically within fill/finish processes and process validation, further enhancing suitability for the role.
