Job Description
Our client, a blue-chip multinational Biopharma company based in Cork, now seeks a Senior Quality Assurance Specialist to work in their fast-paced cGMP manufacturing environment role.
Main Responsibilities: provide QA ownership for products manufactured in area of responsibility, including supporting the QP for review and approval of batch records of Drug Substance, while ensuring quality systems are adhered to and associated site procedures are maintained in compliance with regulations (cGMP, FDA).
This hire will provide QA leadership relating to the compliance, documentation, audits, and batch release type activities in the manufacture of pharmaceutical products.
Responsibilities of Senior QA Specialist, Biotech:
Lead production personnel in deviation investigations, change proposals, qualification and validation.
Review and approval of change controls, observations/ deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents.
Lead the evaluation of third party vendors for raw materials, intermediates and packaging components.
Review and approval of GMP documents associated with qualification and validation including, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes.
Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
Batch disposition, including approval of batch records, for API and Intermediate batches & approval of CoA’s.
Monitoring of GMP compliance, GMP programs including data integrity and systems by ensuring a regular presence the area of responsibility.
Participation in the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures
Requirements of Senior QA Specialist, Biotech:
Bachelor’s degree qualification in Microbiology, Chemistry, Analytical, Biochemistry or similar discipline.
4+ years’ experience in a similar role, supporting QA operations in a Biopharma/Biologics facility in a cGMP environment.
Experience working in cross functional teams and proven ability in decision making.
Proven auditing experience in cGMP and regulatory (FDA, EMEA) guidelines.
Proven experience in documentation and approval for batch release of product.
Very strong communication and people skills – interaction with production, engineering, suppliers, other sites.
Deep understanding of cGMP compliance requirements and regulatory expectations
Training and demonstrated proficiency in root cause analysis methodology
Advanced problem solving skills.
For further details, please contact Larry on +353 (0) 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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