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Quality Validation Lead

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

Quality Validation Lead

Job Overview
Provide support to the Quality and Training Department in developing and maintaining qualification and validation processes across the full scope of manufacturing activities.

Essential Duties and Responsibilities
  • Manage all operational validation activities within the PQS;
  • Ensure all validation programs are designed to achieve the right regulatory approval;
  • Develop and implement compliant validation systems and strategies;
  • Coordinate with all department managers and Quality Assurance to endure the operation of a validated environment according to GMP and other regulatory requirements;
  • Manages the process for the creation of documentation and requirements to include but not limited to the following:
    • Validation master plan;
    • Computer systems validation plans;
    • Equipment validation plans;
    • Cleaning validation plans;
    • Utility/facility validation plans;
    • Quality Control validation plans;
  • Manage all facets of assigned validation projects while maintain strong communication with validation team and other departments on project status and assistance needed;
  • To manage activities against required delivery timelines and report progress to project leader/stakeholders;
  • Determine appropriate resources requirements around site plans;
  • Planning, scheduling, and review of validation activities;
  • Provide visibility to the operation on the validated status of product/equipment required for manufacture;
  • Maintain the validation master plan for each validation stream;
  • Provide oversight and validation expertise during development of new product and new technologies;
  • Identify and participate in improvement activities;
  • Ensure all written GMP documents and records are completed in accordance with good documentation practices;
  • Complete or check GMP records as required;
  • Ensure Quality validation staff are trained in the Quality-related procedures and systems of the QMS;
  • Coordinate and completes facility audit inspections according to QMS requirements;
  • Preforms other duties as assigned.

Requirements
  • Minimum Bachelor of Science in science/engineering/computer;
  • At least 3 years’ experience as validation lead/supervisor, ideally within the pharmaceutical, medical, industry or laboratory;
  • Good understanding and application of GMP and regulatory requirements;
  • Experience in the requirements of regulatory bodies, e.g., auditors from the CLA, PICS PE009, ISO 9001 or ISO 17025;
  • Experience in managing validation within a regulated environment;
  • Knowledge of FDA guidance, ICH guidelines, GAMP and/or GEP;
  • Strong communication and negotiation skills;
  • A hands-on “roll up one’s sleeves” approach to work;
  • Excellent organizational and time-management skills;
  • A team player with strong leadership abilities;
  • Flexibility in working hours/days;
  • Attention to detail.

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

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