Hybrid Quality Assurance Analyst I at 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 stakeholders
• Ensure 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 Life
• Key Result Areas
• Adherence to Diversey Quality standards processes / procedures
• FGQI
• FTR   
• COPQ
• Problem Solving Customer Complaints (if any)
• Acquiring / Maintaining new ISO / Halal Certifications across the 3Ps

Educational and Experience Requirements

• Engineer / M.Sc preferably with a Chemical Background
• 6+ years in Quality / Manufacturing 
• Having experience in contract manufacturing QA assurance role could be useful.
• Knowledge of internal QA Tools / SAP QM