Packaging and Labelling Compliance Team Leader - Cirencester, UK
Corin, United Kingdom
Job Description
Corin is seeking a Packaging and Labelling Compliance Team Leader to proactively ensure compliance to the relevant standards for; medical device packaging, labelling and packing machines. The role includes hands-on validation activities and management of a small team. This is a key role within the Validation and Sterility Assurance team and will work closely with the Manager.
Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. Corin offers a unique combination of clinically proven hip amp; knee solutions and world leading technologies, our OMNIBotics amp; OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.
The responsibilities of the Packaging and Labelling Compliance Team Leader are to:
- Monitor and validate all aspects of medical device packaging and labelling at Corin; including transportation testing, shelf life studies, equipment performance, labelling control systems and label content compliance.
- Support the global portfolio of medical devices, including reusable instruments, single use instruments and orthopaedic implants.
- Approval of techncial documentation, labels and packaging bill of materials
- Ensure continuing compliance and improvement of all aspects of the validation strategy pertaining to packaging and labelling.
- Hands on validation of packaging and labelling equipment in the ISO class 7 cleanroom and manufacturing site at Cirencester.
- Manage projects, e.g. equipment validation, product evaluations, introduction of new systems. Chair project team meetings and prepare and present project updates to senior management.
- Participate in multi-functional global teams which may include; Validation, Research and Development, Regulatory Affairs, external contractors and laboratories.
- Proactively ensure regulatory compliance deadlines are met.
- Provide training to operational teams.
- Lead investigations for non-conformances, CAPA and customer complaints.
- Auditee in internal and external audits for packaging and labelling.
- Work closely with the regulatory affairs team to provide written and oral responses to regulatory authority questions.
- Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS amp; Good Manufacturing Practice (GMP) FDA21 CFR Part 820.
- Ensure that process and timeline requirements for Corrective amp; Preventive Actions (CAPA) are met in accordance with Corin’s Standard Operating Procedures (SOPs) and in support of Corin’s Global Objectives for CAPA.
Requirements
The ideal Packaging and Labelling Compliance Team Leader will have/be:
- A degree in a scientific discipline required is preferred
- An ability to deal with a high level of complexity
- Familiar with Good Manufacturing Practices
- Strong attention to detail
- Proven experience with the following standards; 21 CFR 820.75, ISO 13485, MDD, MDR, ASTM, ISO 11607
- Experience of people management would be advantageous
- Strong analytical and problem-solving skills.
- Able to communicate at all levels of business
Benefits
You will receive a competitive salary and annual bonus as well as:
- 25 days holiday plus bank holidays.
- Excellent pension up to 9.7% provided by Corin when you contribute 4%
- Life assurance (6x basic salary).
- Private medical insurance with BUPA for you and your family.
- Subsidised canteen and gym membership.
- Free car parking - close to Swindon, A419, Cheltenham, Gloucester and Stroud.
- Friendly and collaborative working environment
Corin is an equal opportunity employer. Qualified applicants are considered without regard to age, gender, race, creed, colour, national origin, ancestry, marital status, sexual orientation, gender identity, disability, veteran status.