An innovative international pharmaceutical company, focused on discovering and developing new therapeutics, now seek a QA Specialist for a full time position based in their Dublin office.
The successful candidate is required to lead the vendor oversight process and oversee the effective documentation and tracking of QMS activities, ensuring that contract clinical and manufacturing sites maintain compliance with regulations.
Personal fit: the ideal candidate will be a dynamic individual, who is self-driven and capable of working on their own initiative as well as in a team in a fast paced environment.
Responsibilities for QA Specialist:
Manage the Documentation Control process.
Prepare policies and procedures.
Co-ordinate the implementation of the Internal and external audit schedules and ensure the timely completion of audits.
Oversee the effective documentation and tracking of QMS activities, including deviations and change controls, and the implementation of corrective actions.
Lead the vendor oversight process, including analysis of KPIs
Review GCP and GMP documentation as required, such as clinical trial protocols, regulatory submission documents and reports.
Conduct audits of investigator sites, vendors and contractors when required.
Generate and maintain Technical Agreements with suppliers and customers in line with relevant regulatory and business requirements.
Contribute to Company Training procedures as required.
Requirements for QA 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 01-2302400 / firstname.lastname@example.org
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