Job Description Summary We are looking for Quality Operations Specialist - Temporary (6 Months)
Job Description Major Accountabilities
• Perform Batch Record Review and support timely and GMP-compliant batch release activities.
• Ensure compliant documentation lifecycle management, including review, approval, archiving, and control of paper-based and electronic records.
• Prepare, review and approve quality-related documentation, including operational procedures, protocols, work instructions, and controlled documents.
• Support deviation and complaint investigations, including impact assessments, investigation follow-up, and timely closure.
• Support CAPA, actions, change control, internal audit, and Health Authority inspection readiness activities, ensuring timely execution of defined actions.
• Perform batch-wise Audit Trail Reviews in accordance with the approved plan and applicable procedures.
• Perform routine QA walkthroughs and provide QA support to maintain GMP compliance within manufacturing areas.
• Collaborate with Manufacturing, QC, Microbiology, Warehouse, and other cross-functional teams to ensure timely identification, escalation, and resolution of Quality and GMP-related issues.
Obligatory Requirements
• Bachelor’s degree, preferably in Pharmacy, Chemistry, Chemical Engineering, Biology, Bioengineering, Life Sciences, or a related field.
• Good knowledge of GMP and pharmaceutical Quality Systems.
• Basic knowledge of applicable regulatory requirements.
• Strong quality mindset and awareness of GMP requirements.
• Excellent organizational skills with strong attention to detail.
• Ability to work effectively in a team and communicate clearly with cross-functional stakeholders.
• Demonstrates an appropriate sense of urgency and the ability to prioritize tasks in a dynamic operational environment.
• Good command of English, both written and spoken.
Desirable Requirements
• Previous experience or internship in Quality Assurance, Quality Control, or pharmaceutical manufacturing.
• Experience or familiarity with Batch Record Review, deviation management, batch release, or shopfloor QA activities.
• Familiarity with electronic manufacturing and Quality systems, preferably MES.
• Experience in a GMP-regulated pharmaceutical manufacturing environment is an advantage.
Skills Desired Collaboration, Communication, Data Integrity, Digital Fluency, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Problem Solving, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC)