QA Operations Executive - BioPharma

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification, and Automation services to our clients in the pharmaceutical, nutritional, and related sectors.

With offices across Europe, Asia, and the US, our core focus is on consistently delivering high-quality outcomes for our multinational clients.

We are currently looking for a QA Ops Engineer to join us in a permanent role to help us deliver various projects in the Life Sciences Industry.

Key Attributes/Responsibilities

• Provide routine QA shopfloor and QC oversight, including facility walkthroughs, line clearance, housekeeping checks and SOP compliance.
• Review and approve batch records, QC documents, protocols, reports, deviations, CAPAs and change controls.
• Authorise equipment, room and campaign releases, Quality Tagouts and batch usage decisions.
• Manage deviations, laboratory investigations and unplanned events, including root-cause analysis and CAPA follow-up.
• Conduct risk assessments, gap assessments, self-inspections and audit-readiness activities.
• Support regulatory inspections, complaint investigations and quality improvement initiatives.
• Maintain relevant SOPs and checklists and provide training or coaching to team members.
• Monitor quality metrics, periodic product reviews and site KPI reporting.
• Ensure compliance with applicable cGMP, regulatory and EHS requirements.
• Participate in MES design-phase discussions for electronic batch records.
• Review and approve MES-related change controls.
• Review and approve Business Process Design and Business Process Model documentation.
• Approve validation forms and support DRCL activities.
• Provide QA oversight during water runs, placebo PQ runs and production qualification activities.
• Perform or coordinate 100% QA review and approval of PQ execution records.
• Support MES gap assessments, deviation management and resolution of system or process issues.
• Ensure MES implementation complies with GMP, data integrity and applicable validation requirements.

We are currently only Singaporeans and Singapore PRs for this role.

If you'd like to find out about this opportunity or any other opportunity, please forward your CV to Nelson Anthony (careers@pes-international.com).

If you would like to find out about the latest Jobs and Projects we are involved in then do follow us on LinkedIn: https://www.linkedin.com/company/processengineeringspecialists/mycompany/

PES International operates as an equal-opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation, or any other factors with no bearing on employment skills and we confirm that we are happy to accept applications from persons of any background for this role.