Quality assurance Manager

Quality Assurance Management

• Oversee maintain and continuously improve the QMS covering all GxP and healthregulated activities related to the storage distribution and commercialization of healthcare products within the UAE ensuring compliance with MOH GDP and principal company requirements.
• Lead the QA team in implementing and maintaining quality systems procedures and documentation aligned with regulatory and corporate policies.
• Develop implement and enforce Quality Assurance standards and SOPs ensuring operational alignment and readiness for inspections by regulatory authorities and principal company auditors.
• Oversee all QMS activities including CAPAs deviations/investigations change control document control and product release according to partner and regulatory obligations.
• Implement and manage best practice systems across all warehouse and distribution operations covering delivery storage temperature control expiry management damage handling and disposal ensuring adherence to quality and regulatory standards.
• Monitor temperature control mechanisms within the warehouse ensuring operations stay within validated parameters and defined guidelines.
• Ensure compliance with Good Distribution and Storage Practice (GDSP) guidelines as issued by MOH fostering operational excellence across the supply chain.
• Collaborate with crossfunctional teams to ensure qualityrelated contractual obligations are fulfilled across business partners vendors and internal functions.
• Oversee the qualification process of vendors verifying their quality systems and compliance with GDP regulatory and contractual requirements.
• Manage and oversee internal and external audits ensuring inspection readiness facilitating successful inspections by MOH Municipality Quality Assurance and principal companies and minimizing the risk of violations or penalties.
• Facilitate and conduct training programs providing tools techniques and guidance to ensure the team achieves and sustains high quality standards and regulatory compliance.
• Monitor and report quality metrics to senior management providing insights and recommendations to support quality improvement and decisionmaking.
• Identify and report quality violations lead root cause investigations and implement effective corrective and preventive actions (CAPAs) to address nonconformances.
• Ensure timely accurate submissions of regulatory filings and reports maintaining strict adherence to deadlines and compliance requirements.
• Manage all Quality Agreements with business partners and vendors ensuring their validity continuous updates and relevance.
• Oversee the execution of the Individual Training Program to maintain continuous qualification of employees in accordance with regulatory and corporate standards.
• Adequately identify assess and manage quality risks escalating issues to senior management where necessary.
• Oversee the efficient management of product recalls returns and destruction including regulatory notifications dispatch of recall letters to pharmacies and coordination with MOH approval and collection processes in line with internal SOPs.

Imports Exports & Logistics

• Import and Export permit and approval for shipment release from MOH

• Follow up with Logistics department for any import permit requirement
• Communicate with principal companies for the required documents
• Coordinate with the regulatory department to ensure the required documents are attached before submission for registration (valid registration certificate packing list etc.)
• Coordinate with Head of Import/Export at MOH for timely approval.
• Ensure that all the required documents are attached with the import permit before signing (valid registration certificate packing list)
• Ensure physical verification of the shipment as per the import permit and supplier invoice (item description quantity batch number expiry date etc.) before MOH release submission
• Submission of release form along with supplier invoice and a sample from each batch for MOH release approval
• Reexport any item or shipment rejected by MOH and liaise with MOH officials
• Update Logistic team on products for shipment.
• Receive dispatch report from the Quality Officer and ensure timely deliveries
• Ensure the cold storage goods are received by customers in good quality as per the international quality procedure and MOH policy
• Monitor Semi controlled goods from the stage of importation to dispatch ensuring all records are uptodate as per MOH and DOH requirements and submit monthly reports to MOH.
• Receive periodic customer complaint report and ensure necessary actions are taken to enhance customer satisfaction
• Receive and review the report of expired/near expiry items from QA Officer/Assistant
• Ensure that the expired/near expiry goods (within 3 months) have been kept aside of shelves and Oracle is updated with the new location details
• Coordinate with the Department Managers Finance Principal companies and MOH for necessary approvals to disposeoff expired/near expiry items

Relationship Management

• Establish healthy & effective relationship with all concerned personnel at MOH.
• Maintain professional relationship with regulatory authorities
• Communicate with regulatory bodies in Ministry of Health to facilitate successful product launch.
• Ongoing visits and intensive call to all concern people

Qualifications :

• Bachelors or masters degree in pharmacy
• Certification in Supply Chain Management Quality Assurance Management or Lean Six Sigma is desirable.
• Certification in Supply Chain management / QA Management is desirable

Additional Information :

Skills & Professional Requirements:

• Knowledge & experience of regulatory process
• Knowledge of MOH and government regulations relevant to ARABIAN ETHICALS products
• Experience in working with systems such as SAP / Oracle etc.
• Proficient in MS Office especially Excel and Power Point
• Language Skills: Fluency in English and Arabic
• Knowledge of quality processes standards and GMP

Experience Requirements:

• 68 years of progressive experience in Quality Assurance within the pharmaceutical or healthcare industry.
• Minimum of 2 years in a management role leading QA teams or functions.
• Proven track record of managing quality systems regulatory inspections and audits (internal and external).
• Experience in developing implementing and managing process quality controls and designing and delivering training programs.
• Experience with ISO requirements and electronic Quality Management Systems (QMS) in pharmaceutical sector.
• Demonstrated ability to lead change influence stakeholders and drive continuous improvement initiatives.

Attributes and Behaviours:

• Strong knowledge of GMP GDP ICH guidelines and regulatory requirements applicable to pharmaceutical distribution and commercialization.
• Familiarity with MOH and government regulations relevant to healthcare products.
• Fluency in English and Arabic (written and spoken).
• Excellent leadership communication and problemsolving skills.
• Strong strategic mindset with a handson proactive approach to quality management.
• High attention to detail with strong analytical and organizational skills.
• Ability to work effectively in a fastpaced highly regulated environment managing ambiguity and multiple priorities.
• Strong customer service orientation and collaboration skills fostering positive working relationships with internal and external stakeholders.

Remote Work :

No

Employment Type :

Fulltime