A Senior Specialist for External Quality is required for a biopharmaceutical company in West Dublin. The incumbent will be responsible for providing oversight of quality activities associated with drug substance, drug product and manufacturing processes to contract manufacturing organizations (CMO’s) including technology transfers within the External manufacturing realm.
- Serving as Quality Assurance support and SME for Drug Substance, Drug Product and maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant.
- Providing oversight of GMP systems completed by CMO’s and External Supply Chain function related to Drug Substance, Drug Product and Finished Product.
- Providing oversight to continuous quality system improvements and support implementing improvements at CMO’s in compliance, Preventive Maintenance, Deviation Management and Change Control.
- Working closely to build relationships with contract manufacturers quality personnel.
- Working closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events.
- Reviewing contractor documents i.e., Batch records, deviations and change controls to ensure that they comply with company procedures and meet our clients standards.
- Approving specific standard operating procedures and controlled documents issued by contract manufacturing organizations.
- Supporting contract manufacturing organization audits, including pre-approval inspections.
- Developing and issuing quality metrics pertaining to the process quality activities.
- Trends and analyzing quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA.
- Reviewing and assessing deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
- Reviewing Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
- Supporting Quality Assurance to guide various projects and technical meetings, as needed.
- Documenting and reporting compliance issues to management.
- Deputizing for the Manager, External Quality during holidays and occasion of absence as required.
- Any other duties as required by management.
Qualifications & Experience:
- Relevant degree.
- Minimum of 5 years’ GMP related experience in biopharmaceutical / pharmaceutical or related industry.
- Minimum 5 years’ experience of drug substance/drug product/finished product manufacturing processes in a cGMP environment and technology transfers.
- Must have knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing.
- Experience working with contract manufacturing organizations is desiderable.
- Risk assessment and risk management.
- Efficient in SAP, Firstdoc and Trackwise.
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