Quality Assurance Production Specialist

A leading organization in the pharmaceutical manufacturing sector dedicated to ensuring the highest standards of quality and safety in production. The company focuses on delivering innovative solutions within a regulated environment, adhering to strict GMP guidelines and continuous improvement initiatives. The Quality Assurance Production Specialist is responsible for overseeing and supporting pharmaceutical production processes to ensure compliance with quality standards.

This role involves evaluating production activities, supporting quality improvement projects, and maintaining strict adherence to GMP regulations. Responsibilities include ensuring quality assurance within pharmaceutical production, including bulk manufacturing and packaging operations; supporting production teams in managing deviations and quality issues, including deciding whether to halt production if necessary; proposing and implementing improvements to manufacturing processes and technology; providing technical and content support regarding quality matters, including monitoring, investigating, and documenting deviations and complaints; conducting root cause analyses and developing corrective and preventive actions (CAPAs); leading initiatives for process improvements stemming from audits, deviations, or continuous improvement programs; advising on occupational health and safety, product safety, and environmental policies; participating in audits, investigations, and compliance responses; maintaining up-to-date documentation, including SOP reviews, validation protocols, and batch records; contributing to project work, change controls, and staff training efforts; and engaging in business unit meetings and collaborations with internal and external stakeholders.

Requirements include a Master's degree or equivalent in Pharmacy, Chemical Engineering, or a related field; knowledge of aseptic pharmaceutical processes and production control systems; experience working within pharmaceutical manufacturing environments; strong communication, analytical, planning, and reporting skills; proficiency in English, both spoken and written; ability to thrive in a dynamic, regulated setting with attention to detail and quality; and skills in training, knowledge transfer, and teamwork.