- Be responsible for handling and review of the Quality Deviations & Complaints and participates to the relevant investigations.
- Be responsible for the CAPA Management System in terms of updating the relevant database, performing evaluation, effectiveness check and closure of CAPAs.
- Issuance/ review of Product Quality Review reports.
- Be responsible for the training of personnel on quality topics.
- Participate in internal audits and identify non-conformities.
- Communicate with customers regarding quality issues.
- Be responsible for issuing the change controls and performing the follow up upon their completeness.
- Develop, update and review company processes (SOPs), contributing to the desired compliance with the requirements of GMP, ISO standards, customers, and state law.
- Issuance of process and packaging validation protocols and reports.
- Be responsible for performing batch record review and contribute to the quality release activities of final product.
- Follow and comply to all good practices (GMP, GDP), to the Quality Management System, regulatory requirements, internal processes and procedures, company guidelines, the corporate governance code, the Health Safety and Environment (EHS) procedures an
- Ensure and protect data integrity in every action.
- Undertake any other project or responsibility that is assigned by the company, within the broader scope of the position's responsibilities.
experience 1-2 years of experience
qualifications - Bachelors or Master's degree in Chemical Engineer, Chemistry, Biology, Pharmacy or any relevant field.
- Attention to detail and a methodical, investigative and inquisitive mind
- Time management and organizational skills
- Excellent oral and written communication
- Fluent in Greek & English
- 1-2 years of progressive technical/operational leadership experience or equivalent.
- 1-2 Years of pharmaceutical cGMP experience
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QA Operations Officer - Schimatari, Ελλάδα - Randstad Hellas
Περιγραφή
Are you a seasoned QA Operations Officer interested in joining a big global pharmaceutical company? If you're ready to advance your career, we have the perfect opportunity for you.
The QA Operations Officer will be responsible for quality issues related to company's products in accordance with GMP requirements, legislation and approved specifications folders.
key responsibilities