Dear all,
Please share suitable profiles on this below requirement.
NOTE : It’s Not A QA engineer Requirement
Job Title: Quality Engineer
Location: St, Boston, MA
Mandatory Skill : FDA, GMP, ISO, Process Validation, Risk Management, troubleshooting
Description:
QUALITY ANALYST: • A minimum of 4-6 years of related experience.
• Must have Process Validation experience.
• Good technical understanding of manufacturing equipment and processes.
• Knowledge of statistical software packages (e.g. Minitab) with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• Experience working in both an FDA and European regulatory environment in manufacturing/operations.
• A thorough understanding of GMP/ISO regulations and validation regulations
• The ability to perform ‘hands on’ troubleshooting and problem solving.
• Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).
• In-depth knowledge of product/process Risk Management (FDA and ISO standards).
• Strong communication and interpersonal skills.
• Must have the ability to function in a team-based manufacturing environment.
• The ability to collaborate with all levels of management in a cross-functional team environment.
Best Regards
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