- BBBH768193 Jan 19, 2021 Competitive
Brilliant opportunity for an experienced Quality Systems Specialist / CSV Engineer to join a progressive Pharma company based in Cork on a Permanent basis
I am delighted to be working with a Cork based company who are well known in the industry for a great working environment, collaborative team and great staff retention. The business is currently undergoing huge growth and are on the look out for an experienced Quality Systems specialist / CSV Engineer to join their team. This individual will need to have previous experience of being a system owner of an electronic QMS.
The Quality Systems specialist will report into the Quality Systems Manager and will assist in ensuring that the QMS, the associated Electronic QMS software (EQMS), Master Control and other validated electronic systems are operated and maintained in accordance with cGMPs, GAMP, Annex 11, 21 CFR Part 11 and other applicable regulations.
- System owner of the electronic QMS, responsible for the development, integration, modification, operation, maintenance, and upgrading of system.
- Maintaining compliance in accordance with cGMPs, GAMP, Annex 11, 21 CFR Part 11 and other applicable regulations.
- Quality reviewer/approver for quality processes e.g. change controls, deviations, CAPAs, Standard operating procedure (SOP) and other quality related documents.
- Ensure that the QMS is maintained in a complaint manner.
- Co-ordinate Change Control requests and associated documentation from CMO sites
- Provide quality support to other departments in relation to validated electronic systems
- Participate in internal audit program
- Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site and preparation for and/or conducting internal audits
- Ensure Good Documentation Practices are adhered to in line with current Good Manufacturing and distribution Practices (cGMDP)
- Conduct GMP training as required, including roll out of multi-disciplinary cross training and training on the electronic QMS
- Development and/or appraisal of systems for tracking, trending and reporting of Quality/Site Metrics/KPI's.
- Participate in regular team project meetings, keeping Quality Management and team updated on issues and actions which impact the business
- Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required
Education/Training & Experience
- Educated to degree level, ideally B.Sc. in Chemistry, Microbiology or other scientific discipline.
- 6+ years pharmaceutical experience in a highly regulated multinational organisation. Minimum 4 years in a Quality Assurance role.
Knowledge and Skills:
- Prior experience of being a system owner of an EQMS. Experience of maintaining EQMS Master Control or similar application (Trackwise, ETQ) on an enterprise level an advantage.
- Working experience of GAMP5, 21CFR Part 11, CSV, Project Life Cycle and GxP Regulations. Including experience in drafting and reviewing validation documentation.
- In-depth understanding and knowledge of cGMP standards and Quality Management and regulatory principles in a pharmaceutical environment and the ability to implement appropriately
- Experience/Qualification in Root Cause Analysis. e.g. six-sigma Yellow/Green belt
- Experience of generating/developing reports with Power BI or similar application
- Excellent verbal, written, and interpersonal communication skills with ability to communicate at all levels within the organization
- Excellent interpersonal skills, self-motivation and sense of urgency to make decisions based on judgement and integrity, completing assignments on time
- Ability to work effectively with others to accomplish goals in a challenging environment
- Excellent organisational and time management skills with the ability to prioritise and manage projects within a team environment
- Proficient in Microsoft office. Essential experience of being a system owner of GxP EQMS system. Working experience of Power BI or similar application while not essential is a desirable advantage.
If you would like to find out more or are interested in this role click on the 'apply now' button. Alternatively, reach out to Kellie on 021 2300 300 or firstname.lastname@example.org for a confidential discussion
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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Senior Consultant | Engineering Recruitment - Quality & Validation
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