QA Specialist, Compliance
4 months ago
Job Summary
:In this role the Quality Specialist, Compliance is responsible for maintaining the ongoing compliance of the Quality Management System. Quality Specialist, Compliance is responsible for the administration of the Document Management system on site including coordination of all document change request activities for their nominated area of responsibility. The Quality Specialist, Compliance will provide training and analytical support in the operation of the relevant GMP systems (MasterControl, SAP etc.). The Quality Specialist, Compliance is responsible for supporting the onboarding of new hires including participation in the Induction Programme and Annual GMP Training. The role is also responsible for performing data analysis and reporting of Quality System Metrics internally and globally. The Quality Specialist, Compliance will play an active role in ongoing Quality projects as required.
Essential Duties and Responsibilities:
Function as Sub Administrator for the site Quality Event Management System to manage and maintain traceable, accountable Quality Records in compliance with Corporate Guidelines Provide Quality document control oversight on documentation and reports. Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards. Support Global Systems Administrator in software updates and validation relating to the MasterControl System. Responsible for management of Systems Training – developing, scheduling, and performing. Responsible for management of Document Management Training on site – developing, scheduling, and performing. Responsible for management of GMP Training including Induction and Annual – developing and performing. Support generation of data for Management Review. Management of Site Metrics generation (weekly and monthly) including reporting out Globally. Management of off-site Records Management Supplier. Responsible for managing the Process Confirmation program on site. Responsible for ensuring compliance to GMP review requirements to maintain compliance to customer requirements and enterprise procedures. Work cross functionally with individuals and project teams to ensure successful documentation release. Acting as compliance representative on Quality Projects within the site. Participation in Internal Audit Program. Support in preparation and hosting of Third-Party Audits including audit training and control room set up. QMS compliance tracking and trending of issues and patterns to drive improvements. Interface with other West sites with respect to sharing of best practices. Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct. Compliance to all site Environmental, Health and Safety requirements, training, and regulations. Compliance to all local site company policies, procedures, and corporate policies. Other duties as assigned.Basic Qualifications:
A relevant third level qualification combined with 3 years of demonstrated experience work in a medical device or pharmaceutical manufacturing environment.Preferred Knowledge, Skills and Abilities:
A thorough working knowledge of quality systems such as ISO 13485, 21 CFR Part 820 and/or EU GMP is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage. Must have excellent communication and written skills. Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820/EU GMP is preferred. Auditing experience to CFR 21 Part 820, and / or CFR 21 Part 11 is considered an advantage. Must be able to work in a fast-paced environment. Must be able to organize and prioritize tasks; must be detail orientated and self-motivated. Must be able to collaborate across functional lines and work effectively in a team environment. Strong focus on customer requirements. Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description Support and contribute to Lean Sigma programs and activities towards delivery of the set target. Able to comply with the company’s safety policy at all times. Able to comply with the company’s quality policy at all times.Travel Requirements:
Not applicable to this role.Physical and Mental Requirements:
Ability to reason logically and make sound decisions, to consider alternative and diverse perspectives and to communicate effectively both orally and in writing. Read and interpret data, information, and documents. Ability to work as an integral part of a team. Ability to work under pressure. Ability to simultaneously address multiple complex problems. Ability to make independent and sound judgements. Observe and interpret situations, analyze, and solve problems. Ability to understand, remember and follow verbal and written instructions. Ability to complete assigned tasks without direct supervision. This job is classified as sedentary as the candidate will work seated in front of their computer for the majority of their day.-
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