Quality Assurance Technician
Role
We are looking for a Quality Assurance Technician to join our team. The professional will be responsible for perform operational and technical Quality Assurance activities, ensuring that processes, records, and products comply with GxP guidelines, regulatory requirements, and internal quality policies. Execute and monitor Quality System actions to maintain and improve processes and product quality.
Responsibilities
- Issue, review, and approve procedures/documents related to GxP compliance.
- Approve, control, and archive all Quality-related documents.
- Issue batch records for the manufacture and packaging of all products. Keep them updated and control the replacement of obsolete versions.
- Ensure proper Batch Documentation Review to guarantee compliance with procedures prior to batch release, and ensure fulfillment of the "Product Quality Review" (PQR) process.
- Perform room clearance for production.
- Conduct routine production checks to ensure compliance with procedures and GxP standards.
- Register, follow up on, and archive Change Control processes.
- Document and investigate all Complaints in a timely manner.
- Ensure data collection and recording for the investigation of deviations, non- conformities, complaints, and OOS/OOT and monitor the planning of respective CAPAs.
- Initiate and review deviations, CAPAs, change controls, and related documents, ensuring that documentation is appropriate and complies with existing procedures and regulations.
- Participate in the preparation and/or review of protocols and reports for Equipment and Infrastructure Qualification and Process, Cleaning, and Computerized System Validation.
- Monitor Qualification and Validation activities.
- Ensure that packaging material texts in use are those approved.
- Support Audits by organizing documents and evidence.
- Participate in the review of stability study protocols and reports.
- Identify training needs and support team training.
- Participate in the Market Product Recall process.
Requirements
- Degree or Integrated Master’s in Sciences or Engineering.
- Professional experience in the Pharmaceutical Industry in the Quality area (preferred).
- Proficiency in Good Manufacturing Practices (preferred).
- Good oral and written communication skills.
- Knowledge of spoken and written English.
- Computer skills from a user perspective (MS Office).
- Synthesis and communication skills.
- Driver's license (preferred)
- Available immediately (preferred)