Quality Assurance Specialist
1 week ago
Win Medica Pharmaceutical SA is currently seeking for a
motivated
QA Specialist
for our
High Potent
facility in
Tripoli Greece.
The QA Specialist is involved, in a daily basis, in the implementation of the pharmaceutical quality system that is applied in the factory, either by conducting or by monitoring and inspecting the quality related activities.
Main Responsibilities – Duties
- Quality management
: Handles documentation systems, change controls, deviations, investigations, CAPA, annual product reviews, metrics, and supplier evaluations. - Compliance monitoring
: Conduct internal audits, batch record reviews, data integrity checks, and ensure adherence to SOPs and regulatory requirements. - On-floor inspections
: Oversee production, warehouse, and laboratory activities to ensure compliance with GMP and quality standards. - Qualification & validation oversight
: Facilities, equipment, utilities and process. - Cleaning validation
& verification:
Drafts and reviews required studies and protocols, oversees and ensure manufacturing areas and equipment meet stringent hygiene and regulatory requirements. - Risk assessments
: Conduct risk analysis (identify and mitigate potential quality and compliance risks) and writing reports. - Personnel
: Job descriptions, Training programs.
Qualifications
- Bachelor's degree in life sciences, pharmacy, chemistry, biology, engineering, or a related field.
- Excellent communication in English, both written and oral.
- Excellent Knowledge of MS Office (Word, Excel, Power Point).
- Minimum of 2 years' experience in a Quality Assurance department within the Pharmaceutical Industry.
- Experience in oral dosage forms production will be taken under consideration.
- Observational skills, attention to detail and writing skills.
- Knowledge and experience in Good Manufacturing Practices (GMP).
-
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