QUALITY SYSTEMS ANALYST

DePuy Synthes is recruiting for a Quality Systems Analyst, located in Leeds, UK.
his role is primarily responsible for the maintenance of the batch review and release programme, and for the monitoring, trending, and reporting of quality data.
This role is responsible for ensuring compliance with document control procedures and records management processes for the site.
This role must ensure that relevant documentation in the form of procedures and specifications are followed to guarantee compliance with Global Medical Device Standards and Regulations.
Key Responsibilities.
•    Batch record review, correction, and associated document control activities, for Manufacturing and Customs products.
•    Release of all Leeds production lots.
•    Work closely with Operations and Planning Teams to ensure the delivery of complete, accurate and timely batch records.
•    Champion the delivery of GDocP reduction and reporting GDocP trends on amonthly basis.
•    Manage and store DHR documentation effectively to ensure full traceability.
•    Control of the Quality Assurance archive, and batch archiving and scanning activities.
•    Conduct Quality System investigations, action planning and execution activities as assigned by management.
•    Conduct Quality System monitoring, trending and reporting as assigned by line manager.
•    Provide current and historic DHRs as required by customer quality/vigilance/regulatory/auditors functions.
•    Participate in Site Continuous Improvement activities as identified by line management.
•    Support site preparedness activities for all third party audits.
Participate in Internal and External Audits, supporting front and back room activities as needed.
•    Follow company, H S & E and quality standards to enable the site to achieve excellent results.
•    Cary out such further tasks that maybe delegated by the immediate Manager.
Qualifications Qualifications Education.
Minimum requirements:  A Levels (or equivalent) plus GCSE (or equivalent) in English and Mathematics.
Desirable.
2 years experience in the Medical Device or Healthcare industry or similar regulated industry.
Demonstrated knowledge of manufacturing principles and practices, and procedures.
Experience and Skills.
Required:  •    Well-developed organizational skills with an ability to work independently when required.
•    Attention to detail and excellent time management.
•    The ability to work to a deadline, to cope under pressure and react to changing requirements.
•    In addition, the ability to work as part of a team to achieve results.
•    Versatile – readily grasps technical detail outside own Specialty.
•    Good numerical and literacy skills.
•    Ability to read and follow written instructions.
•    Computer Literacy.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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