QA Vacancy At Pharmaplast company
Pharmaplast company located in Free-zone, Alexandria, Egypt is hiring in Validation and Calibration Dept. A Validation and Calibration Specialist.
Responsibilities:
1. Machine Validation:
Support the preparation and implementation of IQ, OQ, and PQ validation reports for new equipment, processes, and systems to ensure compliance within the manufacturing environment.
Collaborate with Production to assess machine functionality, critical parameters, and product impact.
Work with QC to ensure all tests meet acceptance/rejection criteria.
Ensure all validation documents are complete, up-to-date, and stored in an audit-ready manner.
2. Sterilization Validation
Define sterilization parameters (temperature, pressure, humidity, gas concentration, exposure time, aeration time).
Perform Installation Qualification (IQ) by ensuring sensors and controllers are calibrated and validating sterilizer performance through empty chamber cycles.
Execute Performance Qualification (PQ) by performing half-cycle studies using biological indicators (BIs) with known resistance.
Evaluate worst-case product placement and load configurations to ensure process reliability.
Conduct periodic requalification (annually) to maintain validation compliance.
Prepare final validation reports summarizing compliance with ISO 11135 and regulatory standards
3. Clean room Validation:
Approve SOPs, validation protocols, and acceptance criteria for tests (e.g., particle count, airflow, microbial monitoring).
Ensure compliance through direct witnessing of critical tests (HEPA integrity, airflow patterns, etc.).
Address deviations, failures, and corrective actions as needed.
Maintain complete validation documentation and compliance records.
4. Software Validation:
Prepare software validation reports and ensure compliance with regulatory requirements.
Review validation documentation with the software engineering team.
Finalize reports and ensure approval from all responsible parties.
5. Calibration:
Oversee calibration activities managed by third-party service providers.
Ensure calibration labels are updated and non-compliance (OOT) issues are addressed.
Investigate any OOs results and issue NCR for any device not calibrated during the calibration round for any reason.
Review final calibration reports provided by the service company. and ensure all data is complete, accurate, and meets regulatory compliance.
Qualifications and Requirements:
Education Background: Bachelor Degree in Science, Electro-mechanical Engineering Or any other relevant certificates.
Experience: Fresh Graduates up to 3 years of experience relevant to the job.
Residence: Alexandria resident is a must.
Interested Candidates should send their CVs on CV@Pharmaplast-online.com with Validation and Calibration Specialist in mail subject.