Represent QA in multi-disciplinary teams focused on production facility build and laboratory move ... Interface with Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC departments to resolve ...
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Represent QA in multi-disciplinary teams focused on production facility build and laboratory move ... Interface with Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC departments to resolve ...
Msat In Pharma information
What is the difference between Msat In Pharma vs Clinical Research Associate?
| Aspect | Msat In Pharma | Clinical Research Associate |
|---|---|---|
| Required Credentials | Bachelor's degree, often with certifications in clinical trials or pharmaceutical sciences | Bachelor's degree, often with certifications in clinical research or Good Clinical Practice (GCP) |
| Work Environment | Pharmaceutical companies, biotech firms, or contract research organizations (CROs) | Clinical trial sites, hospitals, or research organizations |
| Employer & Industry Usage | Primarily in pharmaceutical and biotech industries | In clinical trial management and monitoring |
Msat In Pharma and Clinical Research Associate roles share similar educational backgrounds and certifications, often working within the pharmaceutical industry. While Msat In Pharma focuses on supporting clinical trial processes within pharmaceutical companies, Clinical Research Associates primarily monitor and manage clinical trial sites. Both roles are essential in drug development, but their work environments and specific responsibilities differ slightly.
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Job description
Description:
- The QA Engineer is responsible for ensuring the timely development, review and approval of all engineering, validation and lifecycle documentation, (i.e. SOPs, Change Controls, CAPAs, Deviations), ensuring compliance with corporate procedures, SOPs, cGMP, standards and implementing industry best practices.
Key Accountabilities:
- Responsible for the Quality review and approval of engineering and validation documentation to support requirements Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ); validation master plans, risk assessments, calibration and periodic reviews, etc.
- Participate with plant & external engineering resources on new installations & systems to ensure that factory, site, & commissioning documentation is in accordance with current Good Manufacturing Practices (“cGMP”) & supports validation.
- Support all aspects of the Validation Life Cycle from design through operation and improvements, and the revalidation program.
- Represent QA in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation)
- Create, review, and approve SOPs, Change Control and Corrective Action Preventive Action (CAPA) and additional documentation and quality systems such as SOPs, forms, reports, deviation, etc. as needed.
- Works directly with operating entities, with multiple functions, internal and external, to provide Quality validation support to assure requirements meet project expectation and meet local procedures and regulations.
- Interface with Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC departments to resolve process issues and implement changes.
- Identify, analyze, and manage risk through product life cycle with use of risk management tools.
- Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
- Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
- Participate in internal, client and/or regulatory audits.
- Work with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
- Establish, maintain, trend and report Quality KPI and metrics.
- Participate in Management Review, Quality Review Board Deviation Review Board and Change Review Board as required.
About Unicon Pharma
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
11 - 50 Employees
Headquarters location
Edison, NJ, US
Year founded
2013