Job Highlights:
- Established Fortune 500 MNC in Biopharma industry
- Up to $110,000 per annum (exclude performance bonus)
Job Responsibilities:
- Develop and execute validation protocols (IQ/OQ/PQ) for equipment, processes, and facilities in compliance with regulatory standards.
- Conduct risk assessments and validation impact assessments for new and existing equipment/process changes.
- Prepare and manage validation documentation, including protocols, reports, and work instructions, in alignment with Good Documentation Practices (GDP).
- Review and analyze validation data to determine compliance and troubleshoot any deviations or failures.
- Collaborate with cross-functional teams, including Quality, Manufacturing, and Engineering, to ensure validation objectives are met.
- Ensure that validation activities comply with cGMP, FDA, EMA, and other regulatory requirements.
- Support change control processes by evaluating the impact of proposed changes on validated systems and processes.
- Lead validation activities for new product introductions, equipment installations, and facility expansions.
- Participate in regulatory audits and inspections, presenting validation documentation and supporting audit requirements.
- Perform periodic reviews of validated systems to maintain compliance and update validation status as necessary.
- Train and guide team members in validation processes and best practices.
Job Requirements:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- Minimum of 5 years of experience in validation engineering within the pharmaceutical industry.
- Strong knowledge of cGMP regulations, validation standards, and documentation requirements.
- Proficient in risk assessment and root cause analysis techniques.
- Excellent communication and project management skills.
If you are keen to explore this career opportunity, kindly send a copy of your resume to [Confidential Information] or simply click the button to APPLY NOW! We regret that only shortlisted applicants will be notified.
Chan Ku Ci - R22111446
EA License No: 16C8261
