QA Associate - Sterile Fill & GMP Compliance

LSC, Life Science Consultants; Cork; On-site; EUR 55,000 - 75,000; Full time

Job summary

LSC in Cork, Ireland, is seeking a QA Associate to join a biopharmaceutical site that manufactures sterile drug products for Phase III trials, initial launches and long-term market support. The team focuses on growth, purification, formulation and bulk filling of mammalian cell culture derived APIs.

Key responsibilities include providing QA direction for start-up, technology transfer, operation and continuous improvement of sterile filling; contributing to change controls, protocols and GMP

Qualifications

• Degree or 3rd level qualification in Science or Quality.
• QP qualification would be an advantage.
• 5+ years in pharma/biotech quality.
• Knowledge of FDA/EMEA regulations and GMPs.
• Ability to work independently and drive improvements.

Responsibilities

• Provide QA direction for start-up, tech transfer, operation and continuous improvement of sterile drug product filling operations.
• Provide QA input to change controls, protocols and reports ensuring scope of records are clear and implementation activities are robust and timely.
• Write, review and approve SOPs, WIs, QTA, Master Batch Records, Specifications and GMP documentation.
• Participate in cross-functional teams to address issues in real time to meet timelines.
• Provide QA input to ensure Lot Release of high-quality products in compliance with GMPs.

Skills

Quality management

Sterile filling

Independent working

Improvement initiatives

Education

Science/Quality degree

QP qualification (advantage)

Job description

LSC in Cork, Ireland, is seeking a QA Associate to join a biopharmaceutical site that manufactures sterile drug products for Phase III trials, initial launches and long-term market support. The team focuses on growth, purification, formulation and bulk filling of mammalian cell culture derived APIs.

Key responsibilities include providing QA direction for start-up, technology transfer, operation and continuous improvement of sterile filling; contributing to change controls, protocols and GMP