A Leading biotechnology company in Dublin require a QA Specialist- CMO (contract Manufacturing Organisation) or external quality to join them on a 12-month contract basis to support new product introductions outside their state-of-the-art drug substance and drug product facilities in Ireland.
The QA Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with the technology transfer of drug substance and drug product manufacturing processes to our clients’ contract manufacturing organisations.
- Serve as Quality Assurance for the technology transfer of Drug Substance and Drug Product manufacturing 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.
- Provides oversight to continuous quality system improvements and supports implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs.
- Works closely to build relationships with contract manufacturers quality personnel.
- Works 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.
- Responsible for reviewing contractor documents ie Validation protocols, validation reports, Batch records, deviations and change controls to ensure that they comply with procedures and meet standards.
- Approve SOP’s and controlled documents issued by contract manufacturing organizations.
- Support contract manufacturing organization audits, including pre-approval inspections.
- Develop and issue quality metrics pertaining to the process quality activities.
- Trends and analyses 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.
- Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
- Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
- Supports Quality Assurance to guide various projects and technical meetings, as needed.
- Responsible for documenting and reporting compliance issues to management.
- Any other duties as required by management.
- Experience of drug substance/drug product manufacturing processes in a cGMP environment.
- QA validation experience required.
- Must have knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing.
- GMP related experience in biopharmaceutical/pharmaceutical or related industry.
- Experience working with contract manufacturing organisations.
- Ability to provide project leadership and guide successful completion of Quality projects.
- Ability to exercise judgment with defined procedures and practices to determine appropriate action.
- Ability to operate efficiently in a complex matrix organization and international environment.
- Strong mature leadership and interpersonal influencing skills.
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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