Production Pharmacist at The Biovac Institute

Job description

The Biovac Institute requires a Production Pharmacist to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub-Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.

ROLE SUMMARY

• The purpose of the job is to ensure that all dispensing, formulation and filling visual inspection and labeling and packing activities are carried out as per relevant batch books and SOPs and according to the relevant regulatory legislature (Medicine Control Act, Pharmacy Act & Occupational, Safety and Health Act)
• The incumbent would be responsible to ensure pharmaceutical compliance during production shifts and would be required to work shifts or after hours.
• Project assistance   to ensure compliance to pharmaceutical guidelines, in accordance with cGMP, SOP’s and relevant regulatory legislature.
• Responsible for any delegated activities or responsibilities per the Production Manager, Project Manager and or the relevant Section Head as required.

RESPONSIBILITIES OF THE ROLE

Routine:

• To carry out responsibilities in accordance with the organization’s policies, industry standards and applicable laws.
• Ensure that products are dispensed, formulated, filled, inspected, labeled, packed and stored according to the appropriate documentation in order to obtain the required quality, according to GMP standards.
• Ensure that the relevant batch book documentation is current and assist in the maintenance of compilation of new documentation.
• Assist with the maintenance of relevant SOPs and other department specific documentation.
• Ensure timeous execution of media fills as per regulation.
• Ensure that all relevant Deviations, Change control’s, Notifications, CAPA’s and Risk Assessments, where relevant are completed within the specified time.
• Review and/or approve all production batch documents and relevant SOPs..
• Assist with the maintenance of the department, premises and equipment and appropriate validations where necessary.
• Assist with departmental training and planning of functional activities within the section.
• Identify shortfalls or potential problems and address it appropriately.
• Up-to-date knowledge of formulation, filling, visual inspection and packaging of small volume parenterals, processes and relevant equipment.

Projects:

• Oversee technology transfers /projects into the Production Department to ensure cGMP and regulatory compliance.
• Participate in set up and qualification of equipment and validation of equipment and trial runs.
• Liaise with other project team members for design and procurement of small pieces of equipment and consumables.

Qualifications

Degree in B Pharm or equivalent is essential as well as required to be registered with the South Africa Pharmacy Council.

Knowledge & Experience

• 6 years’ experience in Vaccine / Biotech / Pharmaceutical industry or equivalent would be advantageous.
• 4 years’ experience in cGMP vaccine or pharmaceutical manufacturing.
• Quality and regulatory compliance knowledge, i.e. MCC and WHO would be advantageous.
• Experience in general business management.
• Sound technical ability and hands on approach.
• Experience in having faced successful quality audits.
• Supervisory Experience is advantageous 

Skills

• Analytical thinking
• Budgeting 
• Planning skills
• Decision making
• Reporting and presentation capabilities
• Communication skills (verbal & written)