CooperVision Document Control Specialist in Kent, United Kingdom
CooperVision, a unit of The Cooper Companies, Inc. (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses and related products and services. The Company produces a full array of monthly, two-week and 1-day lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism and presbyopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com .
JOB TITLE: Document Control Specialist
DEPARTMENT: Quality Assurance
WORK PATTERN: Mon-Fri
The primary purpose of this role is to develop, manage and maintain the document control systems in order to support and maintain the effectiveness of the Company Quality Management System.
Management of the company’s Standard Work Instructions (SWI system) ensuring procedures are written in accordance with company requirements and are reviewed and approved in a timely manner.
Creating the monthly QA report of new and revised procedures for Training purposes.
Management of the company’s document control systems and responsible for performing final approval on Quality documents.
Assisting in the development of the document control systems training materials and delivering training.
Creation, modification and QA approval of all Packing and Labelling documents, ensuring that changes are authorized and performed in accordance with company change control procedures.
Creation and modification of Batch Manufacturing Documentation (BMRs) and assisting in development of design and layout to improve their use.
Creation, modification, maintenance and approval of company log books.
Creation and maintenance of Customer specific Certificates of Analysis and Certificates of manufacture.
Review and approval of Bills of Materials.
Review and Maintenance of Device Master Records in conjunction with New Product Development.
To respond to requests for information relating to Quality System documents and records.
Establishing and controlling Bulk Product codes for use by Product and Creative.
KNOWLEDGE, SKILLS AND ABILITIES
xcellent computer literacy, proven familiarity with Microsoft Office Suite, Word, Excel, PowerPoint and Adobe PDF maker.
Excellent written and oral communication skills
Ability to work quickly under pressure
Organization and priority setting skills
Excellent attention to detail
Ability to self-manage and motivate
Strong team work ethics./
This is an office based role
There may be requirements for training at additional company sites for which travel will be required
Prolonged sitting in front of a computer/
Educated to A-level or equivalent
Computer skills qualifications are desirable/
A minimum of three years QA/QC experience within a Medical Device or comparable field.
Previous proven experience of Document Control Systems
Familiarity with the European Medical Device Directive, FDA 21 CFR Part 820 requirements and/or ISO 13485./
Familiarity with the Canadian Medical Device Regulations
Previous experience supporting customer and/or Regulatory Authority Audits
Working knowledge of Good Documentation Practices
PLEASE NOTE THAT THIS VACANCY IS OPEN TO COOPERVISION EMPLOYEES AND EXTERNAL CANDIDATES
Job: *Quality Assurance
Title: Document Control Specialist
Requisition ID: ASH0077