QA Specialist - Bio
Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state-of-the-art technology on their one of a kind manufacturing facility.
Essential Duties and Responsibilities for this QA Specialist role include, but are not limited to, the following
QA Specialist executes the site QA activities in order to protect the safety, quality and efficacy of our client's products, thereby ensuring the availability of correct, safe products, assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.
- Provide quality and cGMP input and oversight for all NPI project activities through commercial readiness for the facility
- Review and approval technical support documentation. (Examples include cleaning, process, method validation).
- Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols)
- Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
- Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
- Responsible for review and approval of Master Batch Records in accordance with internal procedures and GMP principles.
- Responsible for review and approval of Master electronic Batch Record recipes in accordance with Alexion’s internal procedures and GMP principles
- Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs
- Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
- Author, review and approve Quality Related Procedures as required
- Support the Vendor Management Program.
- Support the Raw Material Qualification Program.
- Develop and report quality metrics
Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
- Demonstrated success records in auditing and improvement processes
- Ability to operate efficiently in a complex matrix organization and international environment
- Strong mature leadership and interpersonal influencing skills
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
- Efficient in SAP, EMDS, MES and Trackwise.
- Academic degree in natural or applied sciences (Pharmacy, biology, biotechnology, engineering)
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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