Caribbean HR Solutions
is the Caribbean's premier HR Outsourcing company specializing in Executive Search, Recruiting, HRO and Payroll services. On behalf of our esteemed client, JMCC
, we solicit candidates to apply for the role of:
Quality and Training Manager - Medical Cannabis Industry
This role has overall responsibility for quality assurance, quality validation, quality control, and training teams in support of adherence to all established quality management systems including good manufacturing practices (GMP) and related quality standards. Oversight of documentation and implementation of GMP best practices to meet product quality requirements. Oversight of qualification and validation, continuous improvement, quality risk management, auditing, documentation and records management, quality control testing, and ensuring that personnel adhere to quality processes and guidelines.
Qualifications & Requirements
- Be conversant with best practices to achieve successful GMP certification.
- Author of and reviewer of quality system documents to ensure GMP compliance to PIC/S and other relevant standards (GACP, ISO 9001, GDP).
- Coordinate the organization’s policy and quality risk management framework.
- Review appropriate regulations and legislation and raise corrective actions to ensure ongoing compliance against GMP and other quality standards.
- Ensure laboratory controls are implemented in accordance with GMP.
- Review plans and provide day-to-day quality assurance guidance and support to initial validation and controlled change-related initiatives, identify issues, and communicate Quality requirements.
- Ensure adequate training is provided and complete for the employees in their respective functions.
- Manage all QMS documentation and periodic reviews, as per GMP and other quality standards.
- Ensure adherence to GMP and quality standards, QMS procedures and processes, and relevant guidelines.
- Supervise the effective management of quality systems according to QMS requirements (change control, non-conformances, customer complaints, CAPA etc.).
- Ensure all deviations and non-conformances are reported and evaluated, and that critical deviations are investigated and conclusions recorded.
- Approve any corrective or preventative action prior to implementation on site, all GMP changes made on-site according to PQS requirements as well as all Quality-related risk assessments.
- Collaborate across functions and within Quality to identify areas of improvement and implement enhancements.
- Provide guidance to the cross-functional team, educate and train as necessary on a risk-based approach for deployment of GMP systems.
- Support inspection readiness initiatives, as well as during audits and regulatory inspections.
- Participate in annual product quality reviews.
- Ensure facility and area audits are scheduled according to PQS requirements and ensure they are carried out by the relevant person(s) in a timely manner.
- Assist with the identification of opportunities for continuous improvement.
- Ensure that all critical equipment is placed on a calibration and maintenance schedule.
- Ensure that all GMP equipment, testing method, software, and processes are appropriately validated prior to implementation.
- Approve all qualification, validation, and stability protocols prior to work commencing.
- Ensure that technical and commercial agreements are in place with critical GACP and GMP vendors.
- Ensure all vendors who are selected to provide equipment, materials or services are submitted to the vendor assurance process.
- Ensure vendor qualification files are maintained, and vendors are subject to ongoing monitoring for suitability.
- Lead and guide staff involved in quality activities to achieve the best results.
- Mentor and coach staff, as well as develop and implement training programs to ensure professional and personal development of quality personnel.
- Accept responsibility for the quality of own work; acknowledges and correct mistakes, show up on time, and meet standards, deadlines, and work schedules.
- Promote cooperation and mutual support to achieve goals. Encourages participation and mutual support.
- Respond positively to changing business needs and responsibilities. Adapts approach and methods to achieve results; recovers quickly from setbacks and finds alternatives.
- Develop and foster supportive working relationships, motivation, and engagement.
- Perform other duties as assigned.
Though we appreciate all candidates, only those shortlisted candidates will be contacted.
- Minimum Bachelor of Science Degree.
- 10 years’ experience in a GMP– or ISO–regulated field.
- Experience in the maintenance of pharmaceutical quality systems, including validation, deviations, change control and vendor assurance.
- Experience in the requirements of regulatory bodies, e.g., auditors from the CLA, MOH, PIC/S PE009, or ISO 9001.
- Ongoing training to keep up to date with relevant topics in the industry.
- Reporting of Quality metrics to ensure control is maintained over the Pharmaceutical Quality System.
- Monitoring and reporting GMP performance targets.
- 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.
- Unassailable integrity and ethics.
- Excellent analytical, planning, and organizational skills.
- Commercial awareness to manage risks on a business-wide level.
- Excellent interpersonal and leadership skills.