- Reference: 43213
- Job Type: Permanent
- Location: Longford, Offaly, Westmeath
- Category: Bio-Pharmaceutical
Quality Manager / Permanent role / Midlands Based.
We are working with a growing organisation who are bringing new products from concept to commerlisation to the Global Market. They are in a rapid phase of growth and have a great opportinuty for someone to join at this stage within the organisations journey.
Summary of Role:
This is a key role in the establishment and management of the site Validation Master Plan. The Validation Manager will lead all validation activity across the Manufacturing, Laboratory and Warehouse facilities for the facility
- Assist with the setup & implementation of an effective quality management system including quality oversight and leadership across the site and supply chain related activities.
- Provide input into 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.
- Establish and maintain the site validation plan and all associated validation activities.
- Manage and coordinate validation activities as defined in the validation master plan.
- Serve as technical expert for the Validation process and responsibilities to ensure compliance.
- Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure that validation project plans are understood and in keeping with site objectives.
- Review and approve Validation Plans, Protocols, Summary Reports and other documentation associated with validations and ensure compliance.
- Initiate and implement change control activities in accordance with site procedures
- Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities
- Oversee the execution of Process Equipment Installation and Operational Qualifications, review and approve the Qualification protocols, discrepancies and reports.
- Interface with external consultants and suppliers to ensure successful process and equipment validation.
- Manage the site cleaning validation schedule and ensure CSV compliance across the site.
- Present validation system programmes at internal and external audits as required.
- Write or assist in writing, reviewing and approval of SOPs for Validation and other Projects
- Develop and where appropriate deliver training across the teams regarding the validation programme and metrics.
Qualification and Experience:
At least 3-7 years relevant experience in a Pharma (Sterile) /BioPharma Manufacturing environment.
BSc, MSC, PhD in a relevant discipline (e.g biochemistry, chemistry, process engineering) or equivalent experience.
Supervisory / Management experience.
Good Knowledge of Regulatory Guidelines relating to process development and manufacturing.
Ability to write relevant sections for CTD for Regulatory Submission.
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 firstname.lastname@example.org
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