QA Associate

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 have a great contract opportunity for a QA Associate to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.

If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES

• Provide Quality direction and oversight of the start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.
• Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely.
• Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with Policies.
• Participates within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved.
• Provide Quality input and guidance to ensure Lot Release (Components/Raw Materials/Drug Product) of high quality products in compliance with current Good Manufacturing Practices (GMPs).

ABOUT YOU - ARE YOUR SKILLS A MATCH?

• Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
• Demonstrated experience in Sterile Drug Product Filling and start-up of same.
• Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
• Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!