Deputy Responsible Pharmacist - Durban VACANCY : DEPUTY RESPONSIBLE PHARMACIST About the role • Assume responsibility of the Responsible Pharmacist for batch release •
Initiates batch-related investigations and evaluates the CAPA on those investigations, as appropriate. • Conducting Annual Product Quality Reviews on all THE CLIENT products.
bull; Provide in-house training as per ORP training programme. • Deputise for the Responsible Pharmacist and act as back up for Responsible Pharmacist in their absence.
bull; Supervision and performance management of support staff • Assists the Responsible Pharmacist in maintaining a positive relationship with all relevant stakeholders internally and / or externally.
bull; Ensure ORP’s adherence to targets, as part of an efficient supply chain. • Active involvement in multi-disciplinary team meetings.
bull; Assists in ensuring continuous oversight of manufacturing processes. • Assists the Responsible Pharmacist in maintaining a state of inspection readiness.
bull; Provide pharmaceutical support in decision making processes. Minimum Requirements • B Pharm • Registered with SAPC •
3 years’ experience in a pharmaceutical manufacturing environment • Experience in an aseptic manufacturing plant is essential •
Experience in a sterile environment • Understanding of fractionation principles • Thorough knowledge of cGMP principles •
Computer Literacy (MS Office, SAP, etc.) • Previous Managerial experience in a GMP compliant pharmaceutical company Specific Operational Requirements •
The successful candidate will be required to work an 8 hour day between 08h00 to 16h00 • The successful candidate may be required to work overtime to meet the business needs •
Local travel may be required to meet business needs Key Performance Areas • Batch documentation review for final product release o Facilitates timeous release of conforming batches based on the Projected Batch Release Plan o Evaluates batch notifications in order to establish compliance with validated parameters and company procedures.
o Evaluation of rejects from produced batches • Initiate batch related investigations, as required • Compile Annual Product Quality Reviews per product •
Supervision and performance management of Office of the Responsible Pharmacist support staff • Provide in-house training as per Office of the Responsible Pharmacist training programme •
Deputise for the Responsible Pharmacist and acts as back-up for Responsible Pharmacist in their absence • Supports and assists the Responsible Pharmacist in maintaining a positive relationship with all relevant stakeholders internally and / or externally •
Active participation in Multi-Disciplinary Team meetings • Assist the Responsible Pharmacist in ensuring continuous oversight of manufacturing processes •
Assists the Responsible Pharmacist in maintaining a state of inspection readiness • Provide pharmaceutical support in decision making processes, cognisant of the regulatory landscape Competencies •
Attention to Detail • Initiative • Good Communication & Interpersonal Skills • Analysis • Tenacity •
Integrity • Computer Literate