QA Operations Executive - BioPharma
EFOR (formerly Process Engineering Specialists)
Singapore • Penuh Waktu
Jadilah yang pertama mendaftar
- Pengalaman
- Setiap
- Gaji
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- Lowongan
- 1
- Diposting
- 1 hari yang lalu
- Mode kerja
- Di kantor
- Kelayakan
- Only Singapore citizens and Singapore Permanent Residents are eligible to apply for this job.
- Melanjutkan
- Wajib mendaftar
Tempat Anda akan bekerja
Deskripsi pekerjaan
About the Company and Role
EFOR, formerly known as Process Engineering Specialists, is a global services firm specializing in Project Management, Construction Management, Commissioning & Qualification, and Automation consulting within the pharmaceutical, nutritional, and allied industries. With a presence spanning Europe, Asia, and the US, the company is committed to delivering superior results for multinational clientele.
Job Overview
We seek a QA Operations Engineer for a permanent position based in Singapore to contribute to our Life Sciences projects.
Key Responsibilities
- Conduct routine quality assurance oversight on the shop floor and quality control areas, including facility inspections, line clearance, housekeeping audits, and SOP adherence.
- Evaluate and approve batch manufacturing records, QC documentation, protocols, deviations, CAPAs, change control records, and reports.
- Authorize releases related to equipment, clean rooms, campaigns, quality tagouts, and batch consumption decisions.
- Handle deviations, unplanned lab investigations, root-cause analyses, and follow-up on corrective and preventive actions.
- Perform risk assessments, gap analyses, self-inspections, and prepare for audits and regulatory inspections.
- Assist in complaint investigations and drive quality improvement projects.
- Maintain SOPs and related checklists; provide ongoing coaching and training to team members.
- Track quality metrics, conduct periodic product reviews, and generate site key performance indicator (KPI) reports.
- Ensure full compliance with current Good Manufacturing Practices (cGMP), regulatory guidelines, and Environmental Health and Safety (EHS) standards.
- Participate in Manufacturing Execution System (MES) design discussions concerning electronic batch records and review MES-related change controls.
- Validate business process documentation and approve validation forms, assisting in Document Review and Change Logs (DRCL).
- Support quality assurance during water runs, placebo production qualification runs, and related activities with thorough record review and approval.
- Support MES gap analyses, deviation management, and resolve system/process issues ensuring alignment with GMP, data integrity, and validation requirements.
Eligibility
Applications are open exclusively to Singaporean citizens and Singapore Permanent Residents.
Equal Opportunity Statement
EFOR is committed to equal employment opportunities and does not discriminate based on age, race, religion, sexual orientation, or any non-relevant factors.