Our client is looking for a Quality Control Chemistry Section Head to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site

KNOWLEDGE AND EXPERIENCE
At least 6 years’ experience in vaccine/ pharmaceutical/ biotech manufacturing industry.
? At least 2 years’ experience at junior to middle management level in a laboratory supervisor or manager role.
? Experience in quality management systems within a cGMP facility.
? Experience verifying compendial methods and validating non-compendial methods.
? Experience with root cause analysis and conducting laboratory investigations.
? Demonstrated leadership experience.
? Familiar with European Pharmacopeia and United States Pharmacopeia/National Formulary.
Preferred:
? Experience in training.
? Experience in aseptic (sterile) manufacturing.
? Experience in having faced successful local and/ or international quality audits.
? Knowledge of Pharmaceutical Manufacturing related legislation.

Qualifications
Required:
? Diploma or degree in Chemistry or Analytical Chemistry or Biochemistry.
Preferred:
? Post Graduate
? Recognition is given to prior learning and practical experience.

The Key Performance Areas for this position include:
Maintain and build laboratory capacity to meet testing demand.
- Participate in quality audits.
- Participate in technology transfer projects.
- Ensure that the laboratory complies with all safety, quality, and cGMP 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.
Align section focus areas and outputs to the business’s objectives.
- Conduct section planning and execute activities within own scope of accountability.
- Adequate capacity planning and performance delivery in line with strategic, tactical and operational plans.
- Role profiling, goal setting and performance management of supervisors and staff within the section.
- Accountability for own and team's personal and professional learning & development to ensure technical and leadership bench strength within the section.
- Ensure accurate and documented delegation of ongoing operational activities in the event of key staff members’ absence in line with the related policies and SOP’s.
- Conduct effective employee relations in accordance with labor legislation, company policies and procedures and address any performance and conduct concerns and risks timeously.
Conduct effective and comprehensive costing, budgeting and expense management for own section, taking all overlapping site activities into consideration.
- Ensure that OOS and OOT investigations are initiated and completed to the correct standard.

Technical Competencies:
? Passion for analytical chemistry and for QC laboratory management.
? Experience performing quantitative analytical measurements using wet chemistry and instrumental techniques.
? Experience with maintenance and troubleshooting of analytical instrumentation (e.g. HPLC, UV/Vis Spectrophotometer, IR Spectrophotometer).
? cGMP vaccine manufacturing- quality and regulatory compliance & best practice knowledge e.g. Pics, MCC requirements, European Pharmacopoeia and US Pharmacopoeia.
? Total Quality Management & Quality Management Systems.
? Technical trending & report writing.
? Coaching & mentoring of peers & staff.
? Intermediate to advanced user of MS Excel, Work, and PowerPoint