PRODUCTION PHARMACIST (MANUFACTURING)
About the role
Assists in achieving departmental objectives by completing the tasks below and any related tasks with precision and accuracy and within the defined timelines:
• 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 process efficiency monitoring and product and/or investigation process.
• B.Pharm Qualification
• Registered with SAPC
• Computer Literacy
• At least 2 years working experience ( post community service)
• 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 is preferable
• Experience in a pharmaceutical manufacturing environment will be an advantage.
• SAP experience preferable
• Supervisory experience preferable
Key Performance Areas
• Pharmacist authorisations
Responsible for performing all pharmacist authorisation steps within the manufacturing department by performing duties that include, but are not limited to:
o Perform pharmacist authorisations in manufacturing (ABI, Pharmaceutical, Packing, Plasma Caging) when required in accordance with relevant SOP’s, and as per roster/schedule.
o independently checking and signing each dispensed material and its mass or volume (e.g. paste & powder verification)
o check and sign the addition of each material to the mix (e.g. addition of viral inactivation agents)
o check and sign the identity of the bulk product and printed packaging material;
o check and sign that each filling or packaging line or station is clear of previous product, packaging components, records or materials not required for the planned filling or packaging operations, and that equipment is clean and suitable for use before any filling or packaging is undertaken.
o Opening and closing of production lines.
o Verification of expiry date & printing of expiry labels
o Product formulation.
o Signing for authorisation or verification of production activities, on the relevant documentation at the time the event occurred.
o Completing and auditing production batch documents before submitting to ORP
o Perform all required SAP transactions in a timely manner.
o Audit manufacturing documents, when required
• cGMP & cGPP Compliance, OHS Act and other legislation
Ensure compliance with the Pharmacy Act, Medicines Control Act and related regulations and guidelines, including the Good Manufacturing Practice (GMP) and Good Pharmacy Practice (GPP) guidelines.
o Provide pharmaceutical support to the cGMP initiatives identified by ORP as outlined in THE CLIENT’s Quality Policy by:
o Identifying and driving continuous improvement initiatives through performance of regular self-inspections.
o Ensuring that corrective and preventive actions (CAPA) identified as part of internal and/or external audits are attended to and implemented in a timely manner.
o Identifying where documentation and systems are lacking in terms of process control and cGMP compliance, and resolving the deficiencies.
o Reviewing existing documentation and compilation of new documents to align with existing production processes and facilitate cGMP compliance, taking into consideration the MRF1 (dossier)
o Work within the department to follow SOP’s
o Work within the department to assess and recommend methods for improving quality.
o Report and address all dispensary related problems, queries and non-conformances timeously.
o Attend training courses as required.
o Champion compliance on a daily basis as a corporate lifestyle and standard approach to daily work.
o Adhere to Department of Labour regulations concerning standby, call-out, overtime and hours of employment.
o Ensure compliance with the OHS Act.
To conduct cGMP- related training for personnel in collaboration with ORP and Manufacturing HODs by:
o Identifying training needs and providing recommendations on the structure and content of any training to be conducted
o Liaise with THE CLIENT Training Coordinator via ORP to arrange training logistics
o Provide pharmaceutical related training to manufacturing staff in conjunction with ORP & HOD. Conducting post-training assessments to evaluate effectiveness of training and competency of staff.
• Process Efficiency Monitoring and Product Investigation
o Conduct allocated manufacturing or product investigations either as lead investigator or as a member of the cross-functional team
o Critically evaluate processes with respect to Good Manufacturing Practice (GMP), Good Pharmacy Practice (GPP) and Good Warehousing Practice (GWP)
o Motivate and support the adoption of process enhancements to departments concerned
o Report on outcome of projects to relevant stakeholders, as required.
PRODUCTION PHARMACIST (MANUFACTURING)