E-DRUG: Looking for experienced expert for QAf potential suppliers DR Congo (Short-term)
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Dear all,
I+solutions is looking for an experienced expert for quality audit of potential suppliers in DR Congo (Short-term)
About I+solutions
i+solutions is an independent, international not-for-profit organization, specializing in pharmaceutical supply chain management for low and middle income countries. Our key areas of expertise include
* Procurement & Supply Services
* Training & Consultancy Services
* Innovative Projects
i+solutions is a young and dynamic organization located in Woerden with a local presence and offices in Washington DC, Burundi, DRC, Nigeria, South Africa and Rwanda. In Woerden we employ 60 persons and work with sub-contractors across the globe.
Our clients include international organizations such as WHO, UNFPA, Ministries of Health and Foreign Affairs, USAID, the Global Fund, UNITAID, NGO's and private companies. Within the Partnership for Supply Chain Management (PFSCM), we are the major pharmaceutical procurement partner for the Pooled Procurement Mechanism (PPM) for the Global Fund, with a total yearly procurement volume of over 700 million USD. For its work for PFSCM, I+ is looking for an:
Experienced expert for quality audit of potential suppliers in DR Congo (Short-term)
To conduct a quality site assessment of pharmaceutical and health products wholesalers who have been pre-selected by our customer in compliance with the WHO MQAS/GDP.
The expert is expected to carry out the following key tasks:
1. To conduct and lead a quality on-site assessment of a health and pharmaceutical wholesalers located in DRC. The auditor is expected to use the provided audit tool which follows the principles of WHO cGMP/MQAS/ GDP. The auditor is expected to review quality documentation in advance and develop an audit plan and focus areas for an audit.
2. To deliver an inspection report written in the World Health Organization format detailing the results of each audit using the relevant USA Title 21 Current Federal Regulations Chapter 11, 210, and 211 , and/or PIC/S Guide/EudraLex Volume 4 (and annexes) and/or the relevant World Health Organization (WHO) Technical Report Series (TRS).
3. The report must also include deviations and non-conformities to the WHO cGMP/ MQAS/GDP standard. The report must clearly define and categorize the observed deficiencies and recommendations on corrective/preventative actions required for each, to facilitate corrective actions and preventive actions (CAPA) by the wholesaler.
4. To ensure that any non-conformities/ deviations from the WHO MQAS/GDP standard have been addressed with CAPA by each wholesaler before issuing the final report. This must be done by checking for evidence of implementation for each within 30 calendar days of the report being sent to the wholesaler.
5. To provide our customer with procurement recommendations in terms of WHO cGMP/MQAS/GDP compliance on purchasing based on the inspections and the follow up.
To help us achieve our ambition we are looking for
A regional/national expert with a degree in pharmacy, with relevant/recent expertise on auditing/pre-qualification of manufacturers and/or wholesalers for WHO cGMP/MQAS / GDP; conversant in both French and English. Most document review in French, technical report in English.
What will i+solutions offer
The suitable candidate will be offered a short-term consultancy contract, (approx. 18 days), site visits planned for end March/April 2018. Daily rates are in the range of 250-350 USD, depending on experience and qualifications.
Interested candidates are invited to submit their short motivation letter, CV and availability in March/April 2018 ultimately Sunday January 28th 2018 to
businessdevelopment@iplussolutions.org
Carole Piriou <CPiriou@iplussolutions.org>