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Job Ref. ID:

50525

Job Title:

Distributor & Affiliates Manager - QA Compliance

Division:

QA Compliance

Country:

UNITED ARAB EMIRATES

Work Location:

UAE (RAK head office)

Job Type:

Distributor & Affiliates Manager - QA Compliance

Employment Type:

Full Time Employment (Un-limited Contract)

Job Description:

Purpose:

He / She will manage distributor qualification and oversight distributors. Also, He / She will lead distributor communication to fulfill HA queries and required documents, and will be responsible to face external quality audits regulatory/customer audits hosting and audit management. To adhere with the cGMP &GDP principles and to maintain them in an effective manner and will support on Julphar affiliates activities including identification, screening, and qualification of distributors in conjunction with the Julphar distributor qualification program and distributor Management. In addition to Support onsite regulatory related review inquiry response & ensure compliance with current regulatory obligations, guidelines & requirements, support in circular assessment, Support Quality Technical file preparation as per approved quality standards.

Key responsibilities & Accountability:

Key Responsibilities • Manage day to day activities and Leading the team of QA affiliates/Distributor to ensure no overdue or pending actions. • Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource for raised changes and projects, mentor and share experience with colleagues • Ensure the adherence of affiliates and distributors with cGMP ‎principles and to maintain them in an effective manner. • Responsible for the ‎compliance of Quality Management System for all Julphar affiliates and distributors. • Lead the qualification process (including all the stakeholders’ steps) for a new distributor. • Support and following for distributor qualification through completion of Agreement & Questionnaire, owning distributor quality oversight system to ensure that distributors are operating in compliance with cGMP. • Lead the process of quality oversight for Julphar affiliates. • Ensure end to end responsibility and completion of tasks for distributor management (qualification, ‎selection, oversighting and re-qualification). • Work with the candidate distributor to ensure adequate remediation of any gaps identified in the audit through following up for the agreed CAPA plan. • Coordinate with distributors to ensure local complaint handling and coordination activity (receiving, investigating, response and closure), product surveillance activity, recall management, corrective action execution, and change control committee. • ‎Issue/archive the communications between Julphar and Distributors. • Maintain proper system related KPIs’ and trending in a way that allow continuous improvement ‎culture. • Regulatory transmission: Support global RA functions in RAK, in applying standards for regulatory relevant information. Review RA inquiry response as per updated guideline), including review of all quality related documents, including but not limited to (MFM, FPD, CCF,ect) • Health Authority Communication Letters: Coordinate and\or respectively prepare timely letters to support registration activities & license maintenance consistent with the agreed HA letters strategy. • Maintain tracker update for Regulatory files inquiry under review in timely manner. • Support in following Circular assessment by concerned stakeholders & ensure its Proper assessments, update tracker& Circular Notification relocation in time. • Quality Technical File preparation upon MOHAP request as per approved quality standards, update tracker in timely manner • Regulatory Compliance: support & address issues related to regulatory compliance checks. • Solve complex CMC issues related to the product. • Support in Distributor agreement and questionnaire preparation as per approved standards update tracker in timely manner. • Assess change controls related to Regulatory departments and ensure compliance • Support and lead investigation related to regulatory department as QA/RA. • Gap analysis against latest guideline requirements to ensure compliance • Lead the team and ensure their development

Key Competencies:

• In-depth knowledge of the industry’s standards and regulations guidelines. • Excellent knowledge of reporting procedures and record keeping. • Business acumen partnered with a dedication to legality. • Methodical and diligent with outstanding planning abilities. • An analytical mind, able to “see” the complexities of procedures and regulations. • Excellent communication skills.

Technical Competencies:

• Extensive Knowledge in GxP and regulatory guidelines.