Production Pharmacist - Durban Verfied

Salary Negotiable Durban, Kwazulu-Natal Durban, Kwazulu-Natal more than 14 days ago 07-01-2020 7:36:33 AM
03-03-2020 7:36:33 AM
PRODUCTION PHARMACIST (API)
About the role
• Oversight and authorisation of pharmaceutical aspects of manufacturing processes within THE CLIENT, 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.
• Identification of continuous improvement interventions in work processes and incorporation of these into production documentation and training.
• Contribute to product and/or process investigation and/or manufacturing projects.

Minimum Requirements
• B.Pharm Qualification
• Registered with SAPC
• 1-year post internship
• 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

Specific Operational Requirements
• The successful candidate will be required to work an 8-hour day, split day shift, between 06h00 to 18h00, as rostered
• The successful candidate may be required to work overtime to meet the business needs

Key Performance Areas
• Performing all Pharmacist authorisation steps within the manufacturing department, as required
• Compliance with the Pharmacy Act, Medicine Control Act and related regulations and guidelines
• Ensure cGMP & cGPP compliance in all operations that the Production Pharmacist is involved in
• To 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, as appropriate

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