Description
The Senior QA Associate will be a core member of the site Quality Assurance team supporting manufacturing operations and will serve as Quality point of contact for manufacturing.Functions:
*Quality representative in non conformance triage and root cause analysis.
*Review and approval of non conformances and CAPAs.
*Write, review and approve Standard Operating Procedures.
*Perform quality walks of manufacturing area and manage actions.
*Performs Quality Audits to ensure compliance with cGMPs.
*Approves Systems validation protocols on behalf of QA.
*Review and approve master batch records.
*Review and approve works orders. Review of electronic and / or paper BR's.
*Compile QC and Manufacturing batch records and reviews for compliance to cGMPs and Product Licenses. Perform status changes, yields and assign expiry date to products. Prepare deviation reports for shipments as required.
*Manage site quality management review meetings.
*Prepare deviation trend reports and Annual Product Reports.
Basic Qualifications:
*Bachelors Degree in Science or Engineering related discipline and min of 3 years of directly related QA / Aseptic manufacturing experience is essential.
Preferred Qualifications:
*Excellent knowledge / experience in aseptic manufacturing.
*Demonstrated ability in problem solving and experience in managing root cause analysis / non conformance /deviation investigations.
*Strong organizational skills, including ability to follow assignments through to completion.
*Enhanced skills in leading, influencing and negotiating.
*Strong knowledge in area of expertise.
*Strong word processing, presentation, database and spreadsheet application skills.
*Strong communication (both written and oral), facilitation and presentation skills.
*Strong skill in working independently and to effectively interact with various levels.
*Ability to evaluate compliance issues.
To find out more about Real please visit www.realstaffing.com