Job Description
QA Compliance Specialist, Analytical Chemist
Our client, a blue-chip multinational pharma company based in Dublin, now seeks an Analytical Compliance Specialist for their Global API business.
The successful candidate will be responsible for analytical technical transfers and project management from this pharmaceutical company to CMOs or from CMO to CMO. Ability to prioritise, organise and manage multiple tasks to tight deadlines is required to perform this role.
This is a contract role, rolling month to month for up to a 12 month period. This role has the possibility of going permanent for the right candidate.
Responsibilities of QA Compliance Specialist, Analytical Chemist:
- Coordinating & managing analytical technical transfers to CMO partners, developing project plans and implementation of the transfers in a timely fashion.
- Ensure GMP compliance and review & approve analytical method validation documentation & activities at CMOs to determine compliance with ICH requirements and manage remediation of gap analyses at the parent company or CMO.
- The candidate will also provide technical support to the QP and Quality Operations Managers in relation to same.
Requirements for QA Compliance Specialist, Analytical Chemist:
- Bachelor’s Degree in Science or similar technical discipline.
- Minimum of 4 years’ experience in a Quality Control position within the Pharmaceutical industry. Both API and Drug Product experience is desirable.
- Previous experience in analytical technical transfer and a proven track record of successful project implementation is required.
- Excellent organisational and administration skills are required in addition to strong interpersonal skills.
- A positive attitude and the ability to work well in a team environment is essential for the role.
For further details, please contact; Larry on 0+353 1-2302400 / larry@rftgroup.ie / www.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.