Website The Biovac Institute
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.
The successful incumbent will report to the Production Manager.
- The purpose of the job is to ensure pharmaceutical compliance during production shifts for the Formulation and Filling area (F & F) in accordance with the Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974, and the company’s policies, procedures and other applicable laws.
- The incumbent will also be trained in and expected to (when required) give pharmaceutical assistance to the Visual Inspection, Labelling and Packing (VLP) Section.
- The incumbent would be responsible to ensure pharmaceutical compliance during production shifts and would be required to work shifts or after hours.
- The incumbent will provide project assistance to ensure compliance to pharmaceutical guidelines, in accordance with cGMP, SOPs and relevant regulatory legislature.
- The incumbent will be responsible for any delegated activities or responsibilities per the Responsible Pharmacist, Production Manager, Project Manager and or the relevant Section Head as required.
RESPONSIBILITIES OF THE ROLE
- Ensures that production activities are carried out in accordance with the company’s policies, industry standards and applicable laws.
- Ensures that products are dispensed, formulated, filled, inspected, labeled, packed and stored according to the appropriate organizational policies and procedures to obtain the required quality.
- Ensures that the relevant batch book documentation is current and assists in the compilation of new documentation.
- Reviews completed batch books within a specified time period.
- Assists with the maintenance of relevant SOPs and other department specific documentation.
- Ensure timeous execution of production activities as per the monthly production plan.
- Ensures that all relevant Deviations, Change Controls, Notifications, CAPAs and Risk Assessments, where relevant, are completed within the specified time and aligned with the cGMP and the organization’s quality requirements.
- Ensures that the maintenance and associated records of equipment within the department are up to date and compliant to cGMP.
- Assists with qualification/validation activities and trial runs where required within the department and ensures pharmaceutical compliance of these activities at all times.
- Assists with departmental training and planning of functional activities within the section.
- Identifies departmental shortfalls or potential problems and ensures that these are addressed appropriately.
- Up-to-date knowledge of formulation, filling, visual inspection and packing of small volume parenterals, processes and relevant equipment.
B Pharm or equivalent and registration with the South African Pharmacy Council.
Knowledge & Experience
- Experience in Vaccine / Biotech / Pharmaceutical industry or equivalent would be advantageous.
- Quality and regulatory compliance knowledge, i.e. MCC and WHO.
- Experience in general business management.
- Sound technical ability and hands on approach.
- Experience in having faced successful quality audits.
- Supervisory experience is advantageous
- Analytical thinking
- Time management
- Attention to detail
- Planning skills
- Decision making
- Reporting and presentation capabilities
- Communication skills (verbal & written)
All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress.
Interested persons to kindly submit their CV’s to firstname.lastname@example.org by 30 June 2018
Kindly note that by submitting your application for this career opportunity you agree that Biovac may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business