Executive - Quality Control

Purplle.com; Vapi; On-site; INR 600,000 - 900,000; Full time

Job summary

Purplle.com in Gujarat seeks a diligent Quality Assurance professional to lead QC/inspection of materials and finished products, ensuring adherence to SOPs and quality standards. You will monitor QC parameters and manage non-conformances with timely reporting.

The role includes spearheading QMS audits, maintaining SOPs, WI, MFR, BMR, and specification sheets, and supporting external/regulatory audits with precise documentation and CAPA follow-up.

Responsibilities

• Perform sampling, inspection, and analytical testing of raw materials, packaging materials, and finished products as per established specifications and SOPs.
• Monitor standard quality control parameters throughout production and ensure strict compliance with quality guidelines.
• Identify non-conformances, out-of-specification (OOS) results, and deviations, ensuring timely reporting and escalation.
• Internal QMS Audits: Prepare schedules, checklists, and conduct internal QMS audits across operational and production departments to evaluate compliance with quality standards.
• QMS Documentation Management: Create, review, update, and maintain critical QMS documents including SOPs, Work Instructions (WI), Master Formula Records (MFR), Batch Manufacturing Records (BMR), and Specification Sheets.
• Audit Records & Reporting: Document audit findings, prepare comprehensive audit reports, and maintain accurate, audit-ready physical and digital logbooks and records.
• External & Regulatory Audits: Assist in preparing for customer, third-party, and regulatory compliance audits, ensuring all documentation is organized and accessible.
• CAPA & Follow-up: Track audit observations, perform root cause analysis (RCA), implement Corrective and Preventive Actions (CAPA), and verify the effectiveness of corrective measures.
• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant ISO/QMS standards.
• Conduct line clearance checks during production shifts and review batch documentation prior to product release.
• Calibrate and maintain QC laboratory equipment, ensuring valid logs and maintenance documentation.

Job description

Role & responsibilities

1. Quality Control & Inspection

• Perform sampling, inspection, and analytical testing of raw materials, packaging materials, and finished products as per established specifications and standard operating procedures( SOP)s.
• Monitor standard quality control parameters throughout production and ensure strict compliance with quality guidelines.
• Identify non-conformances, out-of-specification (OOS) results, and deviations, ensuring timely reporting and escalation.

2. QMS Audits & Documentation

• Internal QMS Audits: Prepare schedules, checklists, and conduct internal QMS audits across operational and production departments to evaluate compliance with quality standards.
• QMS Documentation Management: Create, review, update, and maintain critical QMS documents including SOPs, Work Instructions (WI), Master Formula Records (MFR), Batch Manufacturing Records (BMR), and Specification Sheets.
• Audit Records & Reporting: Document audit findings, prepare comprehensive audit reports, and maintain accurate, audit-ready physical and digital logbooks and records.
• External & Regulatory Audits: Assist in preparing for customer, third-party, and regulatory compliance audits, ensuring all documentation is organized and accessible.
• CAPA & Follow-up: Track audit observations, perform root cause analysis (RCA), implement Corrective and Preventive Actions (CAPA), and verify the effectiveness of corrective measures.

3. Process Control & Compliance

• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant ISO/QMS standards.
• Conduct line clearance checks during production shifts and review batch documentation prior to product release.
• Calibrate and maintain QC laboratory equipment, ensuring valid logs and maintenance documentation.