- Reference: 44447
- Job Type: Permanent
- Location: Laois, Offaly, Westmeath
- Category: Science, Pharmaceutical & Food
MIDLANDS BASED PHARMA/BIO PHARMA ORGANISTAION SEEKING AN EXPERIENCED Quality Manager TO JOIN THEIR GROWING ORGANISATION.
Summary of Role:
As quality manager you will lead in the establishment and maintenance of the quality management function for the facility. Hands on responsibility in the implementation of an effective quality management system providing quality oversight and leadership to the quality team as well as providing quality support to the various departments including Manufacturing, Engineering, Laboratory, Validation and Warehouse functions within the company
- Assume a lead role in the setup & implementation of an effective quality management system including quality oversight and leadership across the site and supply chain related activities
- Lead the creation, modification and maintenance of the Quality Management Systems supporting operational and release functions.
- If qualified act as a back up QP onsite.
- Participate in or lead internal and external audit including 3rd party audits and supplier reviews.
- Participate in the site validation ongoing activities and all associated validation activities
- Partake in validation activities as defined in the validation master plan.
- Interface with cross functional departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure that the quality management systems is effectively implemented and understood and in keeping with quality objectives.
- Review and approve manufacturing and testing records and data, study protocols and reports and other documentation associated with manufacturing, testing or validation studies to ensure compliance.
- Partake in change control activities, deviations, investigations and risk assessments in accordance with site procedures
- Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of quality and compliance as it pertains to site activities
- Oversee the running of periodic quality management and failure management meetings to ensure compliance.
- Interface with external contractors and suppliers to ensure outsourced activities are managed and coordinated in a compliant and timely manner
- Manage the site quality management meetings and internal and external audit schedule and ensure compliance across the site.
- Assume a lead role preparing the site for forthcoming regulatory inspections.
- Write or assist in writing, reviewing and approval of SOPs for Quality and other Projects
- Develop and where appropriate deliver training sessions across the teams regarding the quality programme and metrics.
- BSc, MSC, PhD in a relevant discipline (e.g biochemistry, chemistry, process engineering) or equivalent experience.
- At least 5-7 years relevant experience in a Pharma (Sterile) /BioPharma Manufacturing environment.
- 2-5 year’s management or supervisory experience in a bioprocess development and/or quality assurance environment.
- Good knowledge of regulatory guidelines relating to process development and manufacture including QbD and Risk Management
- Ability to write relevant sections of CTD for regulatory submission
Candidate experience required:
For a confidential discussion and a more detailed job description (or more information on the role), please contact Mary Mullin on 09064 78104 or email email@example.com
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