Reference : DUR001841-SN-1 This leading private, non-profit, pharmaceutical manufacturer is currently seeking the services of a Production Pharmacist, who will be based in the Manufacturing / API Manufacturing department and will report to the Responsible Pharmacist.
About the Role : Oversight and authorisation of pharmaceutical aspects of manufacturing processes, including key steps as identified in the dossier (CTD or MRF1).
Ensure the safety, quality and efficacy (SQE) of finished products, cognisant of legal requirements. Work closely with the Office of the Responsible Pharmacist (ORP), Manufacturing Managers, and Heads of Departments to ensure compliance to cGMP.
Identify continuous improvement interventions in work processes and incorporate these into production documentation and training.
Contribute to product and / or process investigation and / or manufacturing projects. Minimum Requirements : B.Pharm qualification.
Must be Registered with SAPC. 1 year post internship exp. Experience in a manufacturing environment with a firm understanding of GMP principles preferred.
Ability to work independently, with minimal supervision, with due regard to GMP, GPP and the requirements of professional pharmaceutical practice is preferable.
Familiar with SAP / ERP system. Key Performance Areas : Perform all Pharmacist authorisation steps within the Manufacturing dept.
Compliance with the Pharmacy Act, Medicine Control Act and related regulations & guidelines. Ensure cGMP & cGPP compliance in all operations that the Production Pharmacist is involved in.
Conduct cGMP related training for personnel in collaboration with ORP, QA and Manufacturing HODs. Participate in process efficiency monitoring and product investigation.
Assist with manufacturing projects. Competencies : Technical / professional knowledge. Teamwork / collaboration. Good communication (written & verbal) & interpersonal skills.
Attention to detail. Fact finding and analytical ability. Quality orientation. Computer literate. Integrity, initiative, tenacity. R 650 000 Annually