Quality Assurance Specialist (Retainer, Roster)

Contract

This is a LICA Specialist-10 contract. This kind of contract is known as Local Individual Contractor Agreements. It is normally only for nationals. It's an external contract. It usually requires 5 years of experience, depending on education. More about LICA Specialist-10 contracts.

Background Information - Sri Lanka

UNOPS has supported Sri Lanka’s development since 1998, expanding operations in 2005 to support the post-tsunami response and reconstruction process. Within the organization’s mandate in project management, infrastructure, and procurement, UNOPS Sri Lanka implements customized socio-economic development projects that benefit vulnerable people and develop national capacities. Achievements in Sri Lanka include the development of sustainable and climate-resilient infrastructure, procurement services & capacity building, and project management in education, fisheries, roads, health, water supply systems; flood control and sanitation, and integrated solid waste management sectors. UNOPS works closely with Government counterparts and communities to ensure increased ownership, sustainability, and accountability of Projects.

UNOPS Sri Lanka facilitated over $22 million worth of procurement of COVID-19 protection equipment and services in partnership with the World Bank, the Government of Japan, and the United Nations Multi-Partner Trust Fund. Currently, UNOPS is conducting about $5 million pharmaceutical procurement to strengthen the Sri Lanka health system and support the people in need.

In the context of the current crisis in Sri Lanka and the need to increase our capacity in pharmaceutical procurement, UNOPS is looking for Quality Assurance Specialists, who would be deployed to different projects.

Functional Responsibilities

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.

2) Coordination with Stakeholders - 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.

3) Quality Assurance management - 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.

4) Monitoring and Progress Controls - 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.

Competencies

Develops and implements sustainable business strategies, thinks long term and externally in order to positively shape the organization. Anticipates and perceives the impact and implications of future decisions and activities on other parts of the organization.(for levels IICA-2, IICA-3, LICA Specialist- 10, LICA Specialist-11, NOC, NOD, P3, P4 and above) Treats all individuals with respect; responds sensitively to differences and encourages others to do the same. Upholds organizational and ethical norms. Maintains high standards of trustworthiness. Role model for diversity and inclusion.

Acts as a positive role model contributing to the team spirit. Collaborates and supports the development of others. For people managers only: Acts as positive leadership role model, motivates, directs and inspires others to succeed, utilizing appropriate leadership styles. Demonstrates understanding of the impact of own role on all partners and always puts the end beneficiary first. Builds and maintains strong external relationships and is a competent partner for others (if relevant to the role). Efficiently establishes an appropriate course of action for self and/or others to accomplish a goal. Actions lead to total task accomplishment through concern for quality in all areas. Sees opportunities and takes the initiative to act on them. Understands that responsible use of resources maximizes our impact on our beneficiaries. Open to change and flexible in a fast paced environment. Effectively adapts own approach to suit changing circumstances or requirements. Reflects on experiences and modifies own behavior. Performance is consistent, even under pressure. Always pursues continuous improvements. Evaluates data and courses of action to reach logical, pragmatic decisions. Takes an unbiased, rational approach with calculated risks. Applies innovation and creativity to problem-solving. Expresses ideas or facts in a clear, concise and open manner. Communication indicates a consideration for the feelings and needs of others. Actively listens and proactively shares knowledge. Handles conflict effectively, by overcoming differences of opinion and finding common ground.

Education/Experience/Language requirements

Education: - 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.

Experience: - 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.

Language: - Full working knowledge of English is required. - Working knowledge of a local language is highly desirable.

Contract type, level and duration

Contract type: Local Individual Contractor Agreement (LICA) Contract level: LICA-10 Contract duration: Retainer for 12 months with possibility of extension

For more details about the ICA contractual modality, please follow this link: https://www.unops.org/english/Opportunities/job-opportunities/what-we-offer/Pages/Individual-Contractor-Agreements.aspx

Additional Information

• Please note that UNOPS does not accept unsolicited resumes.
• Applications received after the closing date will not be considered.
• Please note that only shortlisted candidates will be contacted and advance to the next stage of the selection process, which involves various assessments.
• UNOPS embraces diversity and is committed to equal employment opportunity. Our workforce consists of many diverse nationalities, cultures, languages, races, gender identities, sexual orientations, and abilities. UNOPS seeks to sustain and strengthen this diversity to ensure equal opportunities as well as an inclusive working environment for its entire workforce.
• Qualified women and candidates from groups which are underrepresented in the UNOPS workforce are encouraged to apply. These include in particular candidates from racialized and/or indigenous groups, members of minority gender identities and sexual orientations, and people with disabilities.
• We would like to ensure all candidates perform at their best during the assessment process. If you are shortlisted and require additional assistance to complete any assessment, including reasonable accommodation, please inform our human resources team when you receive an invitation.
• This position is a home-based position for local national in Sri Lanka.

Terms and Conditions

• For staff positions only, UNOPS reserves the right to appoint a candidate at a lower level than the advertised level of the post.
• For retainer contracts, you must complete a few Mandatory Courses (they take around 4 hours to complete) in your own time, before providing services to UNOPS. For more information on a retainer contract here.
• All UNOPS personnel are responsible for performing their duties in accordance with the UN Charter and UNOPS Policies and Instructions, as well as other relevant accountability frameworks. In addition, all personnel must demonstrate an understanding of the Sustainable Development Goals (SDGs) in a manner consistent with UN core values and the UN Common Agenda.
• It is the policy of UNOPS to conduct background checks on all potential personnel. Recruitment in UNOPS is contingent on the results of such checks.