Jobscope:
- Ensure that the manufacturing facilities, process and systems are validated in full compliance with cGMP and regulatory requirements so as to meet the stipulated product quality standards in line with established specifications of the organization.
- Play a key role in assessing, reviewing and approving changes that may have an impact on the validation status of the facilities, processes and system on site.
- Act as a Validation Coordinator for projects having quality impact, chair the Validation Working Party meetings and lead the conduct of validation activities to ensure that validation/regulatory requirements are met.
- Review and authorize validation protocol documents and reports
- Participate as an audit team members and/or as a subject matter expert.
- Participate in the conduct of investigations relating to customer complaints/ failures
- Perform QA role in New Production Introduction (NPI) projects to ensure that the manufacture complies with GMP requirements
- Lead the cleaning validation programme to ensure that all cleaning methods used are validated in compliance with regulatory requirements
Requirements:
- Min. Degree in Chemical Engineering or other relevant engineering discipline.
- Possess 1-2 years of relevant work experience in the Pharmaceutical or other relevant industry.
- Experience in manufacturing validation which includes Facility, Equipment and Process qualification.
- Good knowledge of GMP and validation
- Good knowledge of quality and manufacturing process knowledge
- Good knowledge of validation system and its principles.
- Excellent problem analysis, technical writing and oral communication skills.
- Good interpersonal skills and a dynamic team player with leadership skills. Able to work and influence a cross-functional team.
To find out more about this opportunity, please contact Fiona Koh
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239
