Job Description

$7K + AWS + VB + allowance5 working days, Mon - Fri, normal office hoursLocation: WestResponsibilities

• 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.

Requirements

• 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

Competitive remuneration package will be offered to the shortlisted candidate.Interested candidates, please send your updated CV in MS Words format stating your last drawn salary, expected salary, notice period and reason for leaving last / past employment(s) and email to recruit@caed.com.sg for priority processing.To find out more job opportunities, visit Career Edge Asia at www.caed.com.sg for all job listings.Please connect us via LinkedIn as follows for efficient messaging:Do Join us at TELEGRAM by searching \xe2\x80\x9cCAREER EDGE JOB OPPORTUNITIES\xe2\x80\x9d to receive fast job alert!Attn: Jace Tay (Registration No.: R1331152)CAREER EDGE ASIA PTE LTD
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

Career Edge Asia