Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:
Skills And Tools:
Job Description
Responsibilities:
- Prepare Cleaning validation master plans, core validation master plans and additional supporting documentation.
- Prepare Cleaning Validation Protocols and Reports for Oral Dosage form products.
- Prepare Cleaning Validation Protocols and Reports for Dermal products.
- Prepare Cleaning Validation Protocols and Reports for Eye Drops products.
- Oversee investigations, out of specification and unplanned events workflows to ensure they are performed correctly, assist in Root Cause Analysis investigations as required.
- Ensure change controls are assessed for impact on validation.
- Preparation and performing Periodic Cleaning verification plan in accordance with validation master plan.
- Scheduling, planning, managing, and executing studies for Media fill and Gowning qualification.
- Generates executes and/or reviews master and completed Media fill protocols, Gowning qualification protocol, summary reports, associated data, deviations for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
- Preparation of SAP validation and verification protocols and reports.
- Preparation of software validation protocols and reports.
Job Requirements
- Bachelor’s degree of pharmacy
- Years of experience not less than 4 years in the same field.
- Have a professional trainings in GMP, GDP, GEP
- Awareness with updated regulations [WHO, FDA and EU guidelines] and guidelines [ISPE, PICs, ICH and ISO].
- Good command of English (spoken and written).
- Good Computer user or related machines required.
- Ability to analyze, and interpret statistical data.