Quality Assurance Analyst I
Solenis
Job Objective
Role is accountable for leading Quality Assurance for contract manufacturing units (incl. QC ,QMS,GMP Audits & Complaint Management).
Primary responsibilities:
Assures quality products and processes by establishing and enforcing quality standards and testing materials and products at 3P/2P.Implements in-process product inspection standards by studying manufacturing methods and devising testing methods and procedures.Handling customer complaints, work with cross functional groups as needed to ensure closure of complaints with proper CAPA / RCA / Six Sigma measures as needed.Driving process capability improvements with cross functional teams using DMAIC approach.Lead Contract manufacturing Management review meetings and ensure QMS is being followed as per ISO 9001:2015 across all contract manufacturing sites in India.Monthly MIS & Metrics reporting and review with stakeholdersEnsure the contract manufacturing units complies with FDA/GMP guidelines.Plan & review of the products to meet the quality standards as per guidelines. Coordination & managing cross functional teams for achieving Quality KPI’s.Plan and lead customer audits at contract manufacturing sites.Ensure all sites are compliant to Halal requirements and are certified for Halal. Ensure the Products meet the Label Standards / Mandatories / Licensing / Shelf LifeKey Result Areas Adherence to Diversey Quality standards processes / proceduresFGQIFTR COPQProblem Solving Customer Complaints (if any)Acquiring / Maintaining new ISO / Halal Certifications across the 3PsEducational and Experience Requirements
Engineer / M.Sc preferably with a Chemical Background6+ years in Quality / Manufacturing Having experience in contract manufacturing QA assurance role could be useful.Knowledge of internal QA Tools / SAP QM
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