QA VALIDATION ($5000-$7000/AWS/VB)
Career Edge Asia
- Singapore
- $5,000-7,000 per month
- Permanent
- Full-time
- Develop and execute validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for various manufacturing equipment and systems.
- Perform risk assessments and validate critical systems such as manufacturing processes, cleaning processes, equipment, utilities, computer systems, and facilities.
- Collaborate with cross-functional teams to develop and maintain validation strategies, plans, and protocols to ensure compliance with applicable regulations.
- Review and approve validation documentation, including protocols, reports, change controls, standard operating procedures, and validation master plans.
- Conduct periodic reviews and requalification activities to ensure ongoing compliance of validated systems.
- Investigate and troubleshoot validation-related deviations, issues, or non-compliance events.
- Ensure compliance with current Good Manufacturing Practices (cGMP), applicable regulatory guidelines, and internal quality standards.
- Provide support during internal and external audits by regulatory bodies and participate in writing responses and corrective action plans.
- Bachelor's degree in Pharmacy, Chemistry, or Life Sciences and above or equivalent.
- Minimum 5 years of relevant experience.
- Knowledge of cGMP regulations and guidelines, including 21 CFR Part 11 and Annex 15 is a plus.
- Excellent communication and interpersonal skills
EA Licence Number: 13C6678
To find out more job opportunities, visit Career Edge Asia at www.caed.com.sg for all job listings.
Email: recruit@caed.com.sgSocial Share:More Information
- Salary Offer $5000-$7000