Section Head Formulation and Filling - Cape Town Verfied

Salary Negotiable Cape Town, Western Cape Cape Town, Western Cape more than 14 days ago 12-09-2018 8:18:41 AM
07-11-2018 8:18:41 AM
Our client requires a Formulation & Filling Section Head to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site.

Required work experience
• At least 6 years’ experience in pharmaceutical/ biotech manufacturing industry.
• At least 2 years’ experience at junior to middle management level.
• Experience in quality management systems within a cGMP facility

Preferred :
• Experience in aseptic (sterile) manufacturing
• Experience in having faced successful local and/ or international quality audits.
• Experience in general business management within a commercial environment
• Knowledge of Pharmaceutical Manufacturing related legislation

Other Requirements
Local and international travel may be required
Own, reliable transport required for possible standby, shift and overtime work
All positions will be filled in accordance with our Employment Equity policy as the client committed to the pursuit of excellence, diversity and redress.

Technical Competencies required
• Processes Development and Review
• Intermediate proficiency in Microsoft Word, Excel, Power point and Project.
• Metric & KPI development
• Technical Report Writing
• Operational Costing & Budgeting
• Statistical Literacy
• Coaching & Mentoring of peers & staff

Key Performance Areas for this position include

Accountable to lead the Formulation and Filling section’s activities including but not limited to:
Ensuring that the Formulation, Filling and Shared Services goals are achieved at the required quality levels (TBI, SAHPRA, WHO and/or other controlling body), within the agreed/ budgeted time frame.
Ensuring undisrupted, punctual and safe operation of staff and processes pertaining to the Formulation, Filling and Shared Services section of Production and the institute’s operations.
Responsible to ensure that the Formulation and Filling section delivers services and solutions in alignment with pharmaceutical quality system requirements.
Ensures compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures and other applicable laws.
Continuously build and support a sound quality assurance culture aligned to cGMP within the organisation
• Full responsibility for Formulation and Filling section within the Production Department.
• Products are produced and stored according to the appropriate documentation in order to obtain the required quality.
• Production records are completed, evaluated and signed by an authorized person before they are sent to the Quality Control Department.
• Ensure plant/ personnel hygiene and cleanliness is maintained within the formulation and filling floor.
• Monitor the status of plant/equipment calibration and ensure maintenance is carried out accordingly.
• Ensure equipment qualification relevant to the section are completed and maintained through the life cycle of the section.
• Ensure clean rooms, utilities, product data are monitored and trended.
• Authorize documents owned by the section, e.g. written procedures, protocols, specifications for quality- controlled goods, sampling instructions, test methods and data sheets, including amendments.
• Process development for formulation and filling processes of vaccines and other products.
• Compilation of manufacturing documents for the formulation and filling of vaccines and other products.
• Ensure required initial and continuing training of section’s personnel is carried out and adapted according to need i.e. staff operating within the cleanroom must be adequately trained on aseptic technique and cleanroom behaviour.
• Manage internal customer relations and communication.
• Initiate investigations for OOS or other investigations, where required