14262093 – QA Specialist IV – Dublin Contractor

This is a 9-month contract with our Biopharma client in Dublin.

Purpose:

The Senior QA Specialist for the Bulk Drug Substance (BDS) facility at the site will be responsible, with management support, for providing quality oversight of activities associated with the manufacture and disposition of bulk drug substances at the site. 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 at the company in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe products 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.

Responsibilities:

• Provide quality and cGMP input and oversight for all start-up project activities through commercial and multiproduct 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 the progress of follow-up actions.
• Responsible for review and approval of Master Batch Records in accordance with Company internal procedures and GMP principles.
• Responsible for review and approval of Master electronic Batch Record recipes in accordance with the Company 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 Qualifications & Requirements:

• Academic degree in natural or applied sciences (Pharmacy, biology, biotechnology, engineering).
• Minimum 5 years in the international pharmaceutical and/or biotech industry with an 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.