Technical Learning & Development Manager at The Biovac Institute

Purpose of the Role:

The Biovac Institute requires a Technical Learning & Development Manager 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 Chief Human Capital Officer.     

 Job Purpose

•  Accountable for the Technical Training implementation and activities including but not limited to:
• Developing training programs and content. Coordinating the activities of technical training to ensure quality outputs and a well - maintained training infrastructure.
• Ensuring that the GMP training meets the needs of the business in terms of GMP compliance, behaviour and adherence to regulations. Ensuring that the GMP training program and content incorporates current guidelines and standards (Biovac, MCC, WHO) relevant to the company
• Responsible to ensure that provided services and solutions are in alignment with pharmaceutical quality system requirements.Build and support a sound quality assurance culture aligned to cGMP within Biovac.

     Key Duties & Responsibilities

• Develop and implement a knowledge management infrastructure within technical training to ensure Intellectual Property is effectively maintained.
• Develop and compile training programs and content to support continuous improvement and capacity building in line with strategy, quality culture and compliance requirements.
• Develop technical training policies, procedures and templates for review.
• Measure deadlines and return on investment against annual training plan.
• Research training solutions and practices and ensure action plans are formulated according to GMP Standards and requirements.
• Develop, customize and update training modules to suit the facility’s training needs, with the focus on enhanced efficient, availability of equipment, quality, product and component knowledge, autonomous maintenance, SOP execution and GMP awareness.
• Develop practical competency assessment schedules against which staff can be assessed as competent, not competent or competent to teach others.
• Ensure SOP, equipment and technical training is rolled out timeously to drive effectiveness and efficiency of both people and instruments.
• Evaluate proposed development plans against operational and GMP requirements.
• Communicate training results to relevant departments and report on complete and incomplete training trends and competency results metrics on a monthly basis.
• Assist with review of key operations critical SOPs to ensure correct integration and reflection of requirements pertaining to operational tasks.
• Customize training in problem/ complex areas, to enable employees to understand and optimize existing systems.
• Identify training shortcomings during OOS investigations and provide and report suitable, specific re-training to eliminate personnel-based risk factors.
• Initiate intervention measures in event of system / operation problems related to staff competence.
• Assist with ensuring that the structure of training material suits the needs for accreditation with the company’s SETA.
• Ensure accurate training data and metrics are always maintained.
• Plan, direct and coordinate training and development activities and requirements according to site requirements.
• Promote in partnership with Human Capital a learning culture to develop staff.
• Ensure GMP Training plan is in place and executed.
• Assist department managers in risk mitigation plans for staff who are not ‘licensed’ to perform their work functions due to failed assessments.
• Provide coaching on GMP training needs to department managers and site.
• Provide technical support for drafting of training modules along with SME’s.
• Review technical curricula of staff
• Source training materials from external vendors where internal customization is not required as well as where customization is required.
• Develop training templates where needed.
• Ensure that information on latest standards and guidelines are available to site and where applicable guidance on changes to standards and guidelines.
• Ensure that any audits on training systems are successful in line with SOP requirements.
• Excellent understanding and working knowledge of Automated Training Systems.

Technical Competencies required to perform this aspect of the role:

• Strong Planning, Organising, Execution & Delegation skills
• Strategic & holistic thinking
• Creative problem solving & innovation skills
• Effective Customer & Customer & another stakeholder collaboration
• Financial acumen
• Commercial awareness
• Action & results oriented
• Assertive & resilient
• Adaptable in responding to change
• Negotiation and influencing skills
• Proactive in mitigating risk
• Clear, timely and effective communication skills both verbally and in writing
• Analytical ability
• Coaching & Mentoring of peers & staff

Technical Competencies required to perform this aspect of the role:

• 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

Experience & industry accreditation/ knowledge

Required:

• At least 8 years’ experience in Technical Training capacity.
• Experience in quality compliance within a cGMP facility.
• Program and project management.
• Participation in monitoring expenditure against approved budget.

Preferred:

• Working knowledge of Pharmaceutical Manufacturing related legislation.
• Experience in aseptic (sterile) manufacturing.
• Accreditation in training facilitation.
• Experience/ exposure in understanding training needs analysis for organizations.
• Experience in having faced successfully local and/ or international manufacturing audits.

Qualifications

Required:

• Degree/Diploma in Microbiology / Biotechnology, Pharmacy or equivalent
• Recognition is given to Prior Learning and practical experience.