Reporting to the Director of Quality and Regulatory Assurance , the quality Manager will be responsible for leading the QA Operations team and collaborating with relevant functions at plant, and vendor levels to help achieve plant objectives and regulatory requirements.
The position will continue to drive process to be RFT quality all the time from incoming to production to , as well as lead plant and global initiatives to improve practices and procedure to ensure expectations and goals achieved.
Europharma Concepts Ltd, is a site that specialised in the production of Cosmetic and Medical Device products. The cleanroom based activities are regulated by cosmetic Regulation No (EC) 1223/2009 the medical device Regulation No (EC) 2017/745.
- Lead the effort to identify opportunities for improvement within department and the plan:
- Develop a collaborative relationship with operations, customer support and key vendors to achieve target quality and improve it when needed.
- Effectively represent plant and function in teams to share / obtain / develop best practice and lead team when needed.
- Understand customer requirements and support delivering them in line with corporate standards.
- Plan for the department’s future, ensure capabilities and succession plans are in place to meet business needs
- Ensure finished goods are released in line with procedure and regulations.
- Support Plant programs to ensure compliance in key areas, See description below.
- Manage a team of quality engineer, technicians, and QC laboratory.
- Investigation and facilitating problem solving of production issues, containment & analysis.
- Foster culture of continuous improvement and support the implementation projects.
- Adherence to regulatory standards including ISO 22716, ISO 13485, ISO 14971.
- Customer complaint evaluation, analysis, reporting and timely closure.
- Complaint trending and monitoring of corrective actions.
- Development, issuance, and implementation of QA documentation.
- Participate in the development, validation and implementation of the manufacturing processes and equipment for existing and new products.
- Manage / execute site quality systems including CAPA, internal and supplier auditing, product release and validation activities.
- Lead Problem Solving, Failure & Root Cause Analysis, Risk Assessment & FMEA activities within the Team.
- Delivering in-house training on quality assurance concepts and tools.
- Act as Subject Matter Expert with respect to Internal/External Auditing for the site
- Manage external audits by notified bodies and customers.
- Manage cosmetic microbiology analysis per ISO 17516
Qualifications About You:
Characteristics of a successful candidate:
- Bachelor’s degree in science related field
- Drive and tenacity for Continuous Improvement
- Experience in products regulated as drugs, medical devices and cosmetics in consumer goods or pharmaceutical products preferred
- Strong presentation skills
- Experience with ISO13485 and/or ISO 22716
- Continuously looking to implement Lean manufacturing in all aspects
- Exceptional leadership and influence skills
- Great collaborator with team members, wider stakeholders and senior management
– Quality KPI
- Quality KPI Consumer complaints management including, data handling, analysis, trending & reporting
- Data driven CI opportunities realized through effective review of information working with internal and external team to delivery