Reporting to the Director of Quality, the Quality Systems Supervisor is responsible for supporting manufacturing by ensuring that performance standards and procedures are being followed, and audit controls are in place to meet business requirements. This role is responsible for leading a team that manages and oversees CAPA system, internal audits, Change Control, document control, completion of Annual Product Reviews, and trending of quality metrics. This position will lead a team of Compliance Specialists, and Doc Control.
Key Role Specific Requirements
- Oversees investigations, CAPA, Internal Audit and Change Control and Document Control Systems per Bimeda procedures, GMPs and regulatory compliance.
- Assigns, leads, reviews, and approves investigations. Evaluates impact on product quality and ensures CAPAs are assigned and followed through.
- Monitors Quality Systems and advises Director on system performance; publishes statistics regarding performance against set goals and makes recommendations.
- Writes Annual Product Reviews.
- Review and approval of quality related documents
- Creates trainings on various GMP related topics and conducts trainings as needed
- Participates in preparing for and hosting facility audits by customers, regulators (such as FDA, HPRA and Health Canada) including responding to corrective actions and/or observations as required.
- Ensures that corrective and preventative actions (CAPA) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs.
- Manages Change Control system, ensures all changes are thoroughly documented, assessed for impact, deliverables are completed thoroughly. Trend and publishes metrics related to change controls.
- Manages Document Control system to ensure document changes are executed as per Bimeda procedures, GMPs and regulatory compliance.
- Responsible for leading and participating in Internal Audit program, performing audits of plant areas, report writing, tracking, and following up on commitments out of audit observations.
- Achieves results through direct reports by communicating job expectations and company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance.
- Perform gap/risk analysis between applicable and current regulatory standards; establish and implement quality plan to bring the site into regulatory compliance.
- Ensures safety of staff through training, policies, procedures, and support of the JHSC meetings, inspections, and initiatives.
- Monitors department and company quality systems and advises management on team performance. Publishes metrics regarding performance against set goals and makes recommendations.
- Other duties as assigned
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies Required for the Role
Leadership The right individual for this role will exhibit strong leadership capabilities. This person will have qualities that include optimism, compassion, self-motivation, and trustworthiness. We are looking for someone who can foster motivation, set clear and specific objectives, be a strong communicator and be a positive example to the team.
Time Management It’s important to excel in time management skills. A good time management professional will know how much time should be spent on each task and should know how to prioritize project duties to make deadline and eliminate downtime.
Technical Expertise Practical and technical expertise will enable the right individual to use their real-world knowledge to repair and fix problems. Ideally this expertise will have been learned in a pharmaceutical manufacturing or aseptic environment.
Essential Requirements
- 3-5 years relevant experience in a regulated pharmaceutical industry including Quality Assurance, Quality Control with 2 of those years being in a leadership role.
- BSc degree in science or related field
- Knowledge of cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing, and packaging processes.
- Must posses leadership qualities to be able to comfortable and successfully interface and communicate with all levels internally and externally.
- Detail oriented with strong collaboration skills
- Understanding of EDMS systems (i.e., ZenQMS)
- Ability to prioritize critical tasks
- Ability to read, write and communicate expertly in English
Desirable
- BSc degree in microbiology, biology or quality management
- 5-7 years’ experience in a cGMP environment
- Knowledge of process validation
- Experience in aseptic manufacturing facility
About Bimeda
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
Your application to us; assumes you have read and agree with our privacy policy
More Info at www.bimedacareers.com
