Quality Assurance Specialist

The Company: A leading pharmaceutical manufacturing organization focused on producing high quality medicines in a highly regulated environment. The company emphasizes quality, compliance, continuous improvement, and operational excellence across its production activities.

About the Role: This role is responsible for supporting and maintaining quality assurance activities within pharmaceutical manufacturing operations. The position focuses on ensuring GMP compliance, investigating deviations, driving CAPA initiatives, and supporting continuous improvement efforts. The successful candidate will work closely with production teams to enhance quality systems and maintain regulatory standards.

Responsibilities: Write and manage production deviations and quality events; monitor manufacturing processes and identify deviations from established procedures; investigate quality issues, complaints, and non-conformances; perform root cause analysis and develop CAPA plans; support compliance investigations and quality improvement initiatives; review SOPs, validation protocols, production documentation, and batch manufacturing records; ensure compliance with GMP and company quality standards; recommend improvements related to product quality, safety, health, and environmental standards; participate in cross-functional quality and compliance projects; provide quality related guidance and support to manufacturing teams; maintain accurate documentation and reporting of quality activities.

Requirements: Master's degree or equivalent academic level; degree in Pharmacy, Chemical Engineering, Life Sciences, or a related discipline; experience in pharmaceutical manufacturing environments; knowledge of aseptic pharmaceutical processes; understanding of GMP regulations and quality systems; experience with deviation management, investigations, and CAPA processes; familiarity with production control systems; strong analytical and problem-solving skills; excellent written and verbal communication skills in English; strong organizational and planning abilities; ability to work effectively in a fast-paced environment; experience reviewing manufacturing and validation documentation.

Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.