Head Regulatory Affairs, Quality Assurance & Compliance Job

Head Regulatory Affairs, Quality Assurance & Compliance Job, Quality Assurance Kenya Jobs 2021, Latest Legal Jobs Kenya 2021, 

Role: Head Regulatory Affairs, Quality Assurance & Compliance

Reporting To: Managing Director             

Department: Regulatory Affairs, Drug Safety & Compliance

Location: Nairobi

 About the role

Our Client is looking for the Head RA, QA & Compliance is a senior management position. The officer ensures that the Company is compliant with Regulatory Requirements, Quality Management and Internal Guidelines within the Region. The Role will also advice Management on any changes in Regulations for both Operational and Strategic Decisions.

The position shall offer Leadership and Mentor the Team in the department to ensure efficiency within all operations.

 Responsibilities

General

  • Brief the company Management on the regulatory status of the Region.
  • Inform the Management about irregularities/ deviations that could be a potential business threat without delay.
  • Train all staff on Compliance and coordinate the compliance declarations with HR.
  • Train the Production and SCM Teams on Quality Processes inGMP & GDP.
  • Appraise the performance of employees reporting to you through the established feedback processes.
  • Establish relationships with Regulatory authorities, Local Industry association(s) through attendance of meetings and working with industry peers to lobby MoH on matters of Pharmaceutical industry.
  • Maintain knowledge on Product Quality and Safety (PQS) through training, Research and attending other Industry learning platforms.

Regulatory Affairs

  • Assess the products registration projects and resource requirements.
  • Support the registration of products by compiling, submitting and following -through on all Marketing authorization with relevant Authorities in-line with Country guidelines.
  • Maintain authorized products by submission of variations and renewals and supplementary marketing authorizations.
  • Maintain licensing requirements by collating records of new products and updating the regulators on the new products.
  • Engage Head of Marketing & Sales, Product Managers on laws and regulations that would affect business processes by providing the changes and required actions.
  • Execute new, renew, amend or terminate Regulatory Service Level / Distributorship agreements with Third Parties.
  • Coordinate the Pharmacovigilance (PV) and Post Marketing Surveillance (PMS) activities within the Region.
  • Create awareness on case/product complaint management by facilitating training based on the relevant standards.
  • Develop a Risk Management Plan (RMP) to mitigate and adequately control risks.

Quality Assurance

  • Implement QMS in line with ISO and Divisional standards by reviewing and understanding divisional SOPs and analysing their impact in local environment and effecting relevant changes.
  • Authorization of documented Quality Management System (QMS) procedures including change control, deviations, corrective and preventive actions, complaints procedures amongst others.
  • Conduct management reviews of the QMS by presenting and tracking performance against standards.
  • Maintain the QMS by analysing processes and identifying discrepancies against requirements and implement updates.
  • Support Quality audits by performing self-inspection, performing External audits, identifying audit queries, drafting audit reports, engaging with relevant parties to implement correction action and following up on agreed actions in line with audit plan.
  • Monitor and support the implementation of the local company SOPs, working instructions, addressing any areas of non-conformance and implementing corrective actions.
  • Coordinate the annual Product Quality Review.

Compliance

  • Training all employees on company Group Code of Conduct and Organizational Guidelines.
  • Administer the Group Compliance E-Learning modules.
  • Conduct and Report the Annual Self Compliance Assessment for company entities.
  • Maintain data integrity by implementing relevant SOPs and documentation practices.
  • Advice on compliance for the various activities that the organization may want to engage in especially those involving Healthcare Workers and Marketing activities.

How to Apply

To apply kindly visit www.nftconsult.com to apply by 12th November 2021.

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