C&Q Engineer

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PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.
Requirements: 

• Bachelor’s degree in Engineering or a Scientific field.
• Experience with Kneat system
• 5+ years of experience in a regulated industry.
• Strong knowledge of cGMP/FDA regulations
• Strong communication skills (oral and written)
• Ability to organize and manage multiple tasks in a fast pace environment
• Attention to detail
• Demonstrated problem solving and analytical skills
• Strong interpersonal skills/Team Player
• High degree of personal integrity
• Strong computer and mathematical skills
• Self-starter, work without close supervision

Summary

• Convert C&Q paper records to true copies in electronic format
• Generation/Update of Traceability Matrix Documentation in Kneat system.
• Identify gaps and issues as part of the process
• Support the development of new C&Q documentation to address gaps including the development of design review documentation, development and execution of test cases and summary reports
• Develop, review and/or update documents following template in Kneat.
• Appropriate disposition (Archiving/Deletion/Destruction or other as applicable per local procedures) of legacy records.
• Develop a list to keep track of the activities and issues identified. Follow-up with approvals
• Provide status during project meetings

PharmaLex is a Equal Employment Opportunity Employer.