Production Pharmacist

SUMMARY:
Production Pharmacist

POSITION INFO:

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

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