PE Global are currently recruiting for a Senior QA Specialist for a client site in Dublin-
Position Summary
- The Senior QA Specialist for the Bulk Drug Substance (BDS) facility will be responsible, with management support, for providing oversight of quality activities associated with the manufacturing and disposition of bulk drug substances. He/she is responsible for ensuring that manufacturing, testing, labeling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the QMS to ensure that quality and compliance requirements are followed in line with business needs.
- The Senior QA Specialist executes the site QA activities in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and 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.
- Principal Responsibilities
- Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for the BDS 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 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
Qualifications
- 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
- English fluency written and spoken (the Company language)
- Efficient in SAP, EMDS, MES and Trackwise.
Education
- Academic degree in natural or applied sciences (Pharmacy, biology, biotechnology, engineering)
Interested Candidates should send their CV to Audrey.mccarthy@peglobal.net or call 0214297900
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