QA BATCH REVIEW OFFICER
Elpen Pharmaceutical Co. Inc.
Πλήρης απασχόληση Μακρινός
Εργασία εξ αποστάσεως
ELPEN Pharmaceutical Co. Inc., the leading Greek Pharmaceutical Company, is seeking a QA Batch Review Officer for its site in Keratea.
Job Description
The QA Batch Review Officer is responsible for ensuring that products are manufactured in accordance with cGMP and internal procedures by reviewing batch records and verifying the accuracy of data. Supports deviation management and product release, ensuring compliance and high-quality documentation.
Responsibilities
Job Description
The QA Batch Review Officer is responsible for ensuring that products are manufactured in accordance with cGMP and internal procedures by reviewing batch records and verifying the accuracy of data. Supports deviation management and product release, ensuring compliance and high-quality documentation.
Responsibilities
- Identify and evaluate batch-related discrepancies.
- Ensure that batch records meet regulatory requirements.
- Conduct detailed reviews of production and quality documents.
- Support audits and inspections by regulatory authorities and customers.
- Collaborate with the Production, Quality Control (QC), and Quality Assurance (QA) departments to resolve issues that arise during the audit.
- Communicate with the relevant departments to correct errors or omissions in records.
- Provide feedback to improve procedures and documentation.
- Participate in the optimization of batch control procedures.
- Training staff in Good Documentation Practices.
- Participating in the drafting of procedures.
- Communicating and collaborating with departments outside the factory regarding product distribution.
- Minimum 1-2 years of experience in a Quality Assurance Division of a Pharmaceutical company.
- University Degree in Health Sciences, preferably in Pharmacy, Chemistry, Chemical Engineering or relevant.
- Good command of English (oral & written).
- Excellent interpersonal skills and ability to work as part of a cross functional team.
- Ability to organize and manage time (multitasking).
- Responsibility and attention to detail.
- Change management.
- A competitive compensation package combined with additional benefits.
- Private Insurance for you and your family.
- Facilities with Parking, enticing restaurant and corporate bus.
- An extensive training program upon induction and throughout employment.
- Prospects for professional growth.
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