What are the responsibilities and job description for the Process Validation Engineer position at TekOne IT Services Pvt. Ltd.?
Protocol Development: Assist in writing and reviewing validation protocols for manufacturing and operations teams, ensuring clarity and regulatory compliance.
Report Writing: Contribute to the creation of validation reports, ensuring alignment with client requirements and expectations.
Batch Record Review: Conduct thorough reviews of batch records to ensure compliance with internal standards and external regulations.
Data Review & Analysis: Review data protocols to confirm their accuracy, logical structure, and regulatory adherence.
Fill/Finish Expertise: Apply your experience in fill/finish processes to ensure validation processes meet required quality standards.
Process Validation: Lead and participate in validation activities to ensure that manufacturing processes consistently produce high-quality products.
Regulatory Compliance: Ensure that all validation activities comply with applicable regulations and standards, including FDA, GMP, and industry best practices.
Qualifications
Bachelor's Degree: Hold a Bachelor of Science in Biochemistry, Biology, or a relevant life science field.
Experience: 7-10 years of relevant experience in process validation, particularly within fill/finish processes.
CDMO Experience: Prior experience working in a Contract Development and Manufacturing Organization (CDMO) is highly preferred.
Client-Facing Role: Demonstrated ability to work directly with clients, with strong communication and problem-solving skills.
Regulatory Knowledge: Familiarity with GMP guidelines, FDA regulations, and other industry standards related to process validation.
Additional Skills
Strong attention to detail with the ability to critically review data and documents for accuracy.
Excellent verbal and written communication skills for interacting with internal teams and external clients.
Ability to work collaboratively in a cross-functional team environment.
Strong organizational skills with the ability to manage multiple tasks and projects simultaneously.
Prior experience in a highly regulated environment is a plus.
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