Senior QA Associate

Preferred Qualifications & Experience:

* Excellent written and verbal communication skills.
* Experience working with dynamic cross-functional teams and proven abilities in decision making.
* Strong organizational skills, including ability to follow assignments through to completion.
* Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.
* Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.

Key Responsibilities:
o Perform all activities in compliance with safety standards and SOPs.
o Write, review and approve Standard Operating Procedures in accordance with Policies.
o Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
o Review and approval of deviations for closure ensuring compliance with appropriate documentation.
o Participates in customer complaint investigations.
o Provides training and advice to staff in order for them to perform their desired functions.
o Observe and provide real-time quality oversight, and support for production unit operations
o Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
o Review and approve cGMP records ensuring compliance with appropriate documentation.
o Support continuous improvement and Operational Excellence initiatives.
o Any other tasks/projects assigned as per manager's request.

Basic Qualifications & Experience:

o University degree. Engineering or Science related discipline preferred.
o Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.



Preferred Qualifications & Experience:
o Excellent written and verbal communication skills.
o Experience working with dynamic cross-functional teams and proven abilities in decision making.
o Strong organizational skills, including ability to follow assignments through to completion.
o Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
o Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.