Quality Assurance Specialist
2 weeks ago
BROS Ltd is currently seeking for a motivated and experienced Quality Assurance Specialist to join a dynamic team. BROS Ltd is a pharmaceutical company established in 1970, in New Kifisia.
Key responsibilities:
· Collaborate with cross-functional teams to ensure that all products and processes comply with internal quality standards and regulatory requirements.
· Ensure that operations across all departments are conducted in alignment with company policies, industry standards, and applicable regulatory frameworks (e.g., GMP, ISO).
· Actively participate in deviation handling, change control, complaint investigations, and provide oversight on site operations.
· Contribute to the preparation and review of SOPs, management of controlled documents, complaint handling, CAPA implementation, statistical evaluations, APQR, OOS investigations, and cleaning validation activities.
· Support preparation for and execution of customer audits and regulatory inspections, including post-audit responses and follow-up actions.
· Drive the effective implementation and ongoing maintenance of the company's Quality Management System (QMS).
· Provide expert guidance and interpretation on GMP compliance, industry standards, and evolving regulatory requirements.
· Lead and support thorough investigations of deviations, ensuring appropriate root cause analysis and timely implementation of corrective and preventive actions.
· Apply critical thinking and ethical decision-making to address complex quality issues and develop robust, sustainable solutions.
· Coordinate Quality Risk Management (QRM) activities, including risk assessments and mitigation planning.
· Proficient in implementing quality systems, continuous improvement initiatives, and fostering a culture of compliance across the organization.
Required Skills & Knowledge
:
- Bachelor degree in Pharmacy, Chemistry, Chemical Engineering, Biology with postgraduate studies in a related field considered an advantage.
- Proven experience of 2-3 years in the Quality Assurance department of a pharmaceutical company, actively engaged in daily Quality Assurance tasks.
- Knowledge and experience of QMS maintenance and SOPs writing
- Highly self-motivated and able to work effectively under pressure, both independently and within teams.
- Excellent multitasking and time management skills
- Highly results-oriented with a strong drive, and passionate about embracing new challenges.
- Fluent in both Greek and English, with excellent verbal and written communication skills.
- Excellent knowledge of MS Office.
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