The main purpose of the role will be to:
Provide day-to-day assistance for commercial QA activities associated with remote/virtual batch disposition. You will ensure assigned tasks are performed in a timely manner to meet batch disposition, supply chain and all associated international GMP/GDP requirements.
Compile & review batch document sets for completeness and compliance to EU GMP.
Resolve manufacturing, testing, packaging and supply chain issues to support batch disposition.
Complete all relevant documentation to support the QP in the release of drug products
Assist the certifying QP in the release of the drug product where required within company systems.
Assist in maintenance of quality systems including complaint handling, deviations/exception reporting, change control, supply agreements, document control, complaint handling, quality metrics reporting, temperature excursion resolution, document control and retention systems, training as determined by the Quality Manager.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
Bachelor's degree (or equivalent) in a related scientific discipline with relevant experience (preferably Biology / Chemistry/ Pharmacy/Life Sciences).
Basic experience in pharmaceutical manufacturing, distribution and control measures.
Experience of working in a GMP environment is preferred.
Basic experience in Quality administered systems (previous use of Trackwise® QMS beneficial.)
Ability to apply technical knowledge and understanding to making appropriate and timely risk based decisions.
You will be able to demonstrate good planning and organisation skills, attention to detail and accuracy - able to follow verbal and written instruction (SOP's).
Quality and process orientation and mindset.
Possession of good verbal and written communication skills.
Excellent system skills - Word and Excel essential, experience with electronic documentation control systems advantageous.
Enthusiastic, positive individual driven to meet targets and standards with a high level of self- integrity and ethical conduct.
If you are successful you will be joining one of the world's premier innovative biopharmaceutical companies.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA41760 in all correspondence.