Job Description
An innovative biopharmaceutical organisation, focused on discovering and developing new therapeutics, now seek to expand their Quality Team with the addition of a QA Specialist Lead role.
The successful candidate is required to ensure that contract clinical and manufacturing sites maintain compliance with regulations. Candidates will either have experience in Drug Product or API manufacturing.
Responsibilities for QA Specialist, Lead role:
The successful applicant will have responsibility for quality assurance activities including but not limited to document control, compliance, internal SOP?s, training, audits (GMP, GLP required GCP preferable), vendor query management, input into regulatory dossier compilation and follow up.
Travel to off-site Contract Manufacturers locations to ensure quality systems are aligned to Technical Agreements.
Work with Ops and clinical trial programs insure regulatory filing submissions.
Provide Quality support for the Contract Manufacturers, for new products introductions or filings.
Requirements for Quality Assurance Specialist:
Honours Bachelor?s Degree in Science at a minimum. Advanced qualification is highly desirable.
5+ years Quality Assurance experience in a pharmaceutical manufacturing.
Ideal candidate will have experience in QA in an API or Product manufacturing facility and GMP auditing experience.
Knowledge of relevant regulatory requirements.
Strong computer skills.
Ability to travel as required.
Excellent communication skills.
The salary offered will depend on experience, including usual benefits.
Please contact Larry on +353 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