Who are the client
Our client is a Cork based expanding pharmaceutical company and are seeking a QA Analyst. You will contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.
Why apply for this role
- Rapidly expanding company
- Excellent training and benefits
- Good work life balance and great working environment
What will I be doing
Product release activities
- By reviewing all documentation associated with batch release to ensure GMP compliance.
- By ensuring the follow-up of the necessary corrective actions & preventative actions implemented in consequence of a quality failure
- By performing investigations, and ensuring a follow-up, following discrepancy, failures and external complaints.
- Participate in KPI meetings to assist the batch release process.
Implementation, maintenance and development of QA systems.
- Reviewing the GMP documentation eg, SOPs, reports, methods, specifications, validation protocols, quality contracts etc.
- By performing the Product Quality Reviews (data collection, graphic analysis?)
- By participating to the review and updating of the regulatory filing (US + European, DMF type 1 ?), with the collaboration of the regulatory department (once a year)
- Writing and reviewing QA department procedures and reports e.g. protocols, SOPs , environmental reports etc.
Auditing and investigations systems:
- By carrying the inspection, investigation, and taking of samples where appropriate, in order to monitor factors which may affect product quality.
- By alerting the QP in case of detection of a discrepancy anomaly or GMP practices discrepancy / non compliances.
Change control activities
- Participation in management and administration of change control activities on site.
Reporting and communication
- By assisting in the preparation and reviewing of QA department reports and metrics eg. monthly quality report, discrepancy reports, exceptions reports, KPI reports.
- By reporting and communication to the QP on key events and issues etc. via normal in house reporting structure e.g. meetings, formal reports etc.
Participate in the development of the quality standard across the site
- Participate in initiatives and action plans for the development of QA and improvement of GMP compliance.
- Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients
- Assist in preparation and presentation of GMP training programmes.
- Represent QA on projects to ensure compliance to GMP
Meet the quality standards
- Ensure QA activities are executed in line with in-house procedures and in compliance with requirements of cGMP
What Do I Need
Third level degree in Chemistry, Biochemistry, Pharmacutical Sciences or equivalent
2- 3 years? experience in a pharmaceutical environment is preferred
Knowledge of GMP
Good organisation skills and time management skills.
Good IT and analytical skills are required
Good team player and being able to work on own initiative
Efficient, flexible and dynamic
How Do I Apply
To apply for this job click on the apply button below or call 086 0449371 for more information