Quality Assurance Specialist (Retainer, Roster), Multiple positions

Under the direction of the Head of Programme, South Asia Multi Country Office, the incumbent will be responsible for the activities of procurement support,  coordination with the stakeholders, quality assurance management, and monitoring and process control.
1) Procurement Support

• Utilize his/her quality management expertise to ensure efficient support in the Bid Solicitation & Evaluation process. 

• Manage the preparation and issuance of various Expression of interests (EOIs), Request for proposals (RFPs) and Request for quotations (RFQs) for the selection of inspection agencies and testing laboratories. 

• Overall Coordinate with stakeholders, related regulatory agency, and manufacture/supplier in case of recall or safe disposal of expired/damaged drugs. 

• Coordinate with suppliers for the timely readiness of goods for the Pre-dispatch inspection and sampling to initiate the timely delivery as per the delivery schedule mentioned in the contract.

• Develop strategies and work plans for the Quality assurance /Quality control (QA/QC) activities. 

• Develop and maintain the project's positioning with various local and international actors to ensure the successful implementation of QA/QC activities. 

• Carry out SOPs in the field of QA - General Documentation Procedure, Flowchart, Training and training, Sampling of products for quality analysis and retention samples, Product inspection, External audits, Pharmacovigilance, Technovigilance, Health alerts and market products, Returns, Recalls and Event Management due to quality failures

• Analyze the risks and opportunities for the QA/QC operations and/or staff and take appropriate measures. 

• Clear the QA/QC activities proposals and reports for submission to donors/government. 

• Handle the quality complaint and do investigation and write the investigation reports to look for the root cause of the complaint. 

• Responsible for the development and maintenance of the QA standards and systems ensuring compliance according to GMP (Good Manufacturing Practice) and Marketing Authorizations. 

• Review the technical specifications and advise suitable modifications for a better-quality product and at the same time allowing maximum competition.

• Work with quality analysis laboratories with ISO 17025 and WHO guidelines for GLP (Good Laboratory Practices).

• Review quality documentation, Produce product quality reviews, Contribute to preventative actions, Review and approve batch manufacturing and packaging documentation, Perform audits.

• Adherence to operational principles and standards of good pharmaceutical procurement, as set out in UNOPS Procurement Manual and guidelines on QA.

• Adherence to operational principles and standards of good pharmaceutical storage and distribution practices in accordance with UNOPS guidelines on QA. 

• Timely procurement and distribution of Quality Assured pharmaceuticals, Diagnostics and health products in accordance with the client needs.

• Development of Quality monitoring sampling plan.

• Development of QA plan.

• A Master Degree in Pharmaceutical Chemistry / Pharmacy or other related field is required. 

• Additional two years of similar experience with a Bachelor's Degree in Pharmaceutical Chemistry/Pharmacy or other related fields may be considered as equivalent.

• Minimum 5 years of professional experience in Quality Assurance (QA) of pharmaceutical and health products at national and international levels preferably in the UN system is required. 

• Expert knowledge and experience of international pharmaceutical procurement and supply systems would be an asset. 

• Working experience in the National drug regulatory authority is preferable. Experience in developing partnership with Government UN agencies is desired

• International experience as well as Sri Lanka experience on QA matters would be an asset. Working experience in developing QA related policies, procedures, tools and guidelines would be a great advantage. 

• Knowledge and working experience of Good Manufacturing Practice /Good Storage practices /Good distribution practices standards established by the World Health Organization would be an asset. 

• Full working knowledge of English is required.

• Working knowledge of a local language is highly desirable.