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Quality Risk Officer

Montego Bay, Saint James
On behalf of our client Jamaican Medical Cannabis Collective, JMCC, Caribbean HR Solutions is soliciting candidates to apply for the following role:

Quality Risk Officer

Job Overview
Oversees the quality risk management (QRM) process, performing risks assessments, risk evaluations and reporting on risks. Involved in continuous improvement, controlling GMP documentation and records.

Essential Duties and Responsibilities
  • Assist with the development, enhancement and implementation of appropriate quality risk management policies, procedures and systems;
  • Perform risk assessment, analyze current risks and identify potential quality risk that are affecting the organization;
  • Identify strategies to minimize and manage risk;
  • Identifies trends, prioritizes, and directs others in implementing recommended risk reduction strategies, while ensuring compliance with PQS and regulations requirements;
  • Monitor high and significant risks regularly ensuring risk management strategies are appropriate and in place which are monitored and evaluated regularly;
  • Demonstrating knowledge of an organizational risk register and the hierarchy of controls;
  • Promoting understanding of risk management;
  • Assist with coordinating facility audit inspections according to PQS requirements;
  • Assist with corrective or preventative action activities prior to implementation on site;
  • Ensure GMP personnel and processes adhere to GMP, PQS procedures and processes, and relevant guidelines;
  • Participate in annual product quality reviews;
  • Assist with the collation and reporting of GMP performance targets to the business and complete technical system reports;
  • Assist is the development of processes and systems to better evaluation risks business wide;
  • Performs other duties as assigned.

Requirements
  • Minimum Bachelor of Science Degree;
  • Certification in Risk Management or Project Management;
  • Minimum of 3-5 years' specific risk management experience in pharmaceutical industry, (ideally API manufacturing);
  • Experience working in regulated quality systems such as ISO and GMP;
  • Experience in analyzing and managing risks within an organization;
  • Experience in the requirements of regulatory bodies, e.g., auditors from the CLA, PE009-14, ISO 9001 or ISO 17025, ISO 31000;
  • Ongoing GMP refresher training;
  • Sound knowledge of US and European Pharmacopeia methods and requirements;
  • Strong knowledge of technical writing;
  • Ability to communicate and work independently with scientific/technical personnel;
  • Self-motivated, detail-oriented, and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities;
  • Ability to conduct internal and third-party audits;
  • Knowledgeable in the CAPA processes;
  • Unassailable integrity and ethics;
  • Commercial awareness to manage risks on a business-wide level;
  • Able to conduct risk assessments using various risk tools and techniques, for e.g., Failure Mode and Effects Analysis, Risk Matrix, etc. to prioritize organization’s objectives;
  • Ability to build risk awareness among staff and provide relevant risk avoidance training;
  • Assist in developing business continuity plans;
  • Ability to collect, analyze and present data related to risks in quality, health and safety in a pharmaceutical company and facilitate actions to address identified risks.

Though we appreciate all candidates, only those shortlisted will be contacted.
 

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