QA Validation

Responsibilities:

1. Develop and execute validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for various manufacturing equipment and systems.
2. Perform risk assessments and validate critical systems such as manufacturing processes, cleaning processes, equipment, utilities, computer systems, and facilities.
3. Collaborate with cross-functional teams to develop and maintain validation strategies, plans, and protocols to ensure compliance with applicable regulations.
4. Review and approve validation documentation, including protocols, reports, change controls, standard operating procedures, and validation master plans.
5. Conduct periodic reviews and requalification activities to ensure ongoing compliance of validated systems.
6. Investigate and troubleshoot validation-related deviations, issues, or non-compliance events.
7. Ensure compliance with current Good Manufacturing Practices (cGMP), applicable regulatory guidelines, and internal quality standards.
8. Provide support during internal and external audits by regulatory bodies and participate in writing responses and corrective action plans.
9. Stay updated on regulatory requirements, industry best practices, and technological advancements in validation methodologies.
10. Train and mentor junior validation staff by providing guidance and sharing knowledge on validation principles and practices.

Qualifications:

1. Bachelor's degree in a scientific discipline such as Pharmacy, Chemistry, or Life Sciences.
2. Prior experience of 3-5 years in a QA Validation role within the pharmaceutical or biotech industry.
3. Thorough understanding of validation concepts, principles, and regulatory requirements (e.g., FDA, EMA).
4. Strong knowledge of cGMP regulations and guidelines, including 21 CFR Part 11 and Annex 15.
5. Experience with validation activities for various systems, such as manufacturing processes, cleaning processes, equipment, utilities, computer systems, and facilities.
6. Proficiency in writing and reviewing validation protocols, reports, standard operating procedures, and other documentation.
7. Familiarity with risk assessment methodologies (e.g., FMEA) and statistical tools for data analysis.
8. Excellent problem-solving and analytical skills, with the ability to identify and address validation issues.
9. Strong communication and interpersonal skills to effectively collaborate with cross-functional teams and regulatory agencies.
10. Knowledge of electronic documentation systems, data integrity, and technology validation is a plus.