81316642-Skills development for the Ghanaian pharmaceutical sector

This assignment contributes to the overall objective of the PharmaVax Ghana programme to ensure that the public and private ecosystems of Ghana"s pharmaceutical industry contribute to more competitive local manufacturing of pharmaceutical products. Specifically, the assignment supports the achievement of the specific objectives and indicators related to component 2 on skills development. Component aims to improve access to practice-oriented and gender-responsive training courses on specialized skill sets needed to grow pharmaceutical and vaccine production sector in Ghana. The hypothesis is that pharmaceutical manufacturers can find and hire qualified workers and professionals locally and engage them in a productive and lucrative local pharmaceutical value chain from R&D and production. This is based on the assumption that private sector stakeholders (including manufacturers) will work together in developing and establishing long-term hands-on training opportunities for needed skills sets. Key partners are Ghanaian vocational and higher education training institutions as well as the public and private sector stakeholders of the pharmaceutical manufacturing sector, in particular manufacturers themselves.

The contractor is responsible for the following two work packages and for achieving the corresponding milestones. These work packages fall under component 2 but there are potentials for synergies and thus need for coordination to the other components, as well as to further activities under component 2 implemented by the GIZ team or financing recipients.

Work package A: Vocational training for the pharmaceutical sector

In addition to highly trained and specialist workers, production floor staff such as qualified machine operators as well as maintenance technicians are needed to expand production and ensure effective and efficient operations. The contractor will support the introduction of a formal technical and vocational education and training (TVET) programme in the area of "pharmaceutical manufacturing process technology" (curricula have already been developed). The training is to be implemented to begin with at one training institution in Accra. If demand and resources allow, it might be expanded in the second year to a second training institution, preferably in Kumasi as the second pharmaceutical industrial centre of the country. Key areas include: 1. Preparation of a detailed implementation concept and plan: 2. training institution(s), qualification levels, target groups, entry requirements, cohort sizes, course duration and training modalities 3. Development of a costing model and a financial and institutional sustainability plan, including fees/pricing/stipends, resource mobilization and partnerships etc. 4. Mobilisation of local and international private sector partners for supporting training implementation 5. Identification of school-based and in-company trainers; finalisation of training materials; delivery of technical and didactical trainings of trainers according to national and, where possible, international standards 6. Mobilisation and procurement of equipment, tools and equipment as well infrastructural upgrades of training institution(s) 7. National accreditation of training institutions, international accreditations and certifications where possible 8. Gender-transformative career guidance and course promotion and gender equitable selection of qualified participants 9. Training delivery at training institution(s) and in companies (workplace experience learning); support to trainees, training institutions, participating companies, trainers; Examination of trainees, recognition of prior learning where appropriate; support to the labour market integration of trainees 10. Monitoring, evaluation and learning, including review and adaptation of course contents, materials and delivery approaches for future cohorts; tracing of graduates

Work package B: Higher education and specialist trainings

The contractor will provide technical advice and assistance to develop at least ten required capacity development measures for qualified specialists in the pharmaceutical sector, on a sustainable basis and in collaboration with well-established institutions for higher-education and specialist trainings in Ghana (e.g. Noguchi Memorial Institute for Medical Research, Kumasi Centre for Collaborative Research). Each course shall be run twice with support from the contractor. The subjects of the short courses are to be determined depending on the needs of the pharmaceutical industry in Ghana but could include areas such as vaccine immunology; bacterial genomics and bioinformatics; good laboratory practice; clinical trials management and monitoring; maintenance training on some advanced equipment used in clinical trials; vaccinology; GMP principles in vaccine manufacturing; biopharmaceuticals and biosimilars development, production, analytics; cGMP compliance and consumer safety; cGMP inspection; pharmaceutical validation management; ICH Q9 quality risk Management; ICH 8 and 9; cleaning validation; data integrity and documentation; dossier development; analytical method validation; product quality review; change management and product lifecycle; drug safety and pharmacovigilance; equipment and facility qualification; engineering.

For each course, this includes notably the follow main tasks: 1. Development of course materials together with training institutions and private sector 2. Identification of trainers 3. Set up of infrastructure / Procurement of reagents and equipment 4. Promotion of the course 5. Selection of participants 6. Certification 7. Sustainability concept

Bidders are required to provide 2 key experts (1 team leader and 1 technical expert) as well as expert pools (national and internation expertise). The tender also includes provision of equipment for partners, activities, travel costs for the experts and loclal subcontracts.