Quality Assurance/Batch Reviewer

Packaging Manufacturer of Cosmetics is seeking a Quality Assurance \ Batch Reviewer to join their team. This position is primarily responsible for reviewing and overseeing the validations executions for all testing, batch processing, equipment, facility and cleaning of cosmetic & OTC manufacture and production.

The Quality Assurance/ Batch Reviewer will be responsible for:

• Reviews and approves validation master plans, validation protocols, validation reports, validation deviations, SOP’S and other validation documentation in support of product release.
• Reviews and coordinates with Tech Service team the validation plan, schedule and organize new & existing validation projects including laboratory equipment, water systems, manufacturing and filling equipment, manufacturing and filling processes, plant systems, storage facilities and cleansing & sanitization processes.
• Managing the validations execution with the appropriate departments and personnel and, to provide them with the correct training of the validation protocol requirements.
• Provides technical input on validation deviations, proposes site-specific validation procedures and shared practices as applicable.
• Coordinates with Tech Service team the qualification IQ/OQ/PQ activities with manufacture, production, sanitization, quality control and outside testing facilities providing leadership, guidance and training.
• Reviews and approves protocols for validation/qualification IQ/OQ, PQ of existing processes, methods and equipment according to approved protocols and SOPs.
• Reviews the validation documents to analyze data, adjust where needed to confirm that a manufacturing or production process has consistent results and meets regulatory standards.
• Troubleshooting / investigating validation-related deviations.
• Maintaining organization and archival of completed validation and qualification document packages.
• Work with Tech Service team, manufacturing and Production to generate Failure Mode & Effects Analysis (FMEA) and risk assessments of new projects.

Job Requirements

• 3+ years relevant experience in validation role (regulated Cosmetic or Pharmaceutical industry)
• Bachelor’s degree in engineering or related science.
• Familiar with validation discipline and processes.
• Familiar with CAPAs, Change Controls, audits & investigations.
• Adept at Microsoft Office suite.
• Positive attitude, to adapt to fast changes, work under a lot of pressure, teamwork and have initiative. Bilingual is a plus.

For immediate consideration, please send resume outlining your related validation experience.