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Warrington, Cheshire, England
Brief job description
Works under the general supervision of the QA Manager. Largely self-directing. Determines and develops approach to work towards achievement of established goals and objectives agreed with the manager.
Where problems of diverse scope must be handled, use of own initiative is encouraged along with judgement and experience.
Networks and shares knowledge within the team, provides guidance and mentors other team members.
Main Position Objectives
Provides focus for the Global Quality Management System working closely with manufacturing and other departments /functions to support, develop and promote consistency, continuous improvement and compliance with Global/Site quality and business requirements. Responsive and proactive in identifying and managing risks to assure product availability and ongoing customer satisfaction. Expected to take initiative and drive change across the business in order to promote both compliance and efficiency.
Recognise that decisions taken have both local and global implications which will in turn influence the Quality Management System and the processes and practices applied.
Closely interacts and builds effective relationships with people across site to promote quality, consistency and compliance.
Provides quality support to manufacturing and NPI projects.
Demonstrates courage and willingness to determine appropriate action and make risk-based, sound and timely decisions. Ensures and maintains compliance with internal and external (ISO18385/ISO 13485 etc) standards and regulatory requirements.
Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is deternied and the appropriate actions are agreed and implemented. Manages corrective and preventive action processes ensuring the timely and accurate resolution of problems identified.
Takes responsibility for the measuring and monitoring of performance against agreed KPI's.
Collates and shares information/data and trending as appropriate through reports and follows up on improvement opportunities.
Actively participates and/or drives EU/Global QMS improvements as required. Actively contributes to the success of the overall QA team and the site. Identifies, advise and implements training/coaching to meet defined Quality Systems requirements.
Performs/takes part in internal audits and external audits as required according to site and global plans.
Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.
Takes responsibility for ensuring timely completion and follow up through to closure.
Required Job Qualification
Degree in a scientific discipline or equivalent experience in a relevant discipline.
Knowledge of ISO Apply/ISO18385 or equivalent standards.
Experience with Quality Improvement Tools (5 Why/pareto analysis/Run Charts).
Experience of CAPA processes & problem solving within CAPA multi-functional teams
Ability to work on multiple tasks at any one time.
Excellent communication and report writing skills.
Ability to recognise deviation from requirements and understanding risks when decision making.
Experience of office packages and general computer skills
Ability to challenge existing approaches to compliance in order to seek improved ways of working.
Ability to coach and influence others is essential.
Type of necessary job experience
Quality Assurance experience in a chemical/biological or pharma manufacturing industry. Experience with cGMP is essential.
Experience with electronic quality tools an advantage e.g. Trackwise/Agile.
Experience with ERP systems an advantage i.e.SAP.
Experience of verification and validation processes and statistics based quality tools
Birmingham, West Midlands, England£ 35 - 60 Per hourBank...Posted 19th February 2018
£ 35 - 60 Per hourPart timeBank...Posted 19th February 2018Closes 19th March 2018Ref HC Birmingham CP
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