Assistant Manager - QA/QC AK Health Tech Pvt Ltd

3.0 - 7.0 years

3 - 4 Lacs

Noida

Work from Office

Role & responsibilities We are looking for highly skilled and process-driven professionals to join our Quality Assurance (QA) team at a cutting-edge surgical gloves manufacturing facility. The ideal candidate will play a key role in ensuring that every aspect of production especially raw material evaluation , packing material testing , process validation , and regulatory compliance meets stringent national and international standards for Class B, C and D medical devices. Quality Management System (QMS): Design, implement, and monitor QMS as per ISO 13485 and MDR 2017 . Maintain SOPs, work instructions, and controlled documents. Regulatory Compliance: Ensure adherence to CDSCO regulations , BIS 13422 (Surgical Gloves), BIS 15354 (Examination Gloves), and GMP guidelines. Support during audits (internal, external, and regulatory). Validation & Process Control: Oversee validation protocols including cleaning, packaging, and sterilisation (ETO/Gamma). Conduct risk assessments , change control , and CAPA implementation. Batch Records Review: Review and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) . Ensure traceability from raw materials to finished goods using batch/lot numbers. Packaging Material Testing & Traceability: Verify and test all packaging materials against relevant standards. Maintain Certificates of Analysis (COA) for inward materials, including packing components. Ensure complete traceability for raw materials , packaging , and finished gloves . Training & Documentation: Conduct training on QA procedures, GMP, and regulatory updates. Manage deviation reports and QA documentation flow across production and QC. Mandatory Requirements: Prior experience in a CDSCO-approved manufacturing facility handling Class B, C & D medical devices. Strong understanding of: ISO 13485 MDR 2017 BIS 13422 / BIS 15354 GMP/QMS documentation Hands-on with internal audits, regulatory inspections, and validation processes. Inward Raw Material Testing: Evaluate incoming latex and other input materials using lab instruments such as viscometers, tensile testers, hardness testers, etc. Test and verify packaging materials as per standard requirements. Attach and maintain Certificates of Analysis (COA) for all inward materials, including packaging materials. Sample Preparation: Prepare glove samples for technical evaluation, customer trials, and tender submissions. In-Process Quality Checks: Monitor ongoing production to ensure compliance with defined AQL levels and physical parameters. Identify and classify critical defects during manufacturing. Packaging & Sterilization Checks: Conduct QC checks at all packing stages: Valeting, Pouching, and Sterilization (ETO/Gamma). Verify packaging integrity and labeling accuracy. Final Product Inspection: Perform thorough inspections of finished goods, including Pre-Dispatch Inspections (PDI) . Traceability & Documentation: Maintain batch and lot numbers for raw materials, packing materials, and finished goods to ensure full traceability. Generate daily QC reports, maintain batch records, and ensure proper documentation flow. Preferred candidate profile Education: B.Sc / M.Sc in Chemistry, Microbiology, or Polymer Science OR B.Tech in Chemical Engineering, Rubber Technology, or Biomedical Engineering Experience: 37 years in QA roles within the medical devices industry (gloves manufacturing preferred) Skills: Proficiency in QA documentation , process audits , and compliance systems Experience with ERP tools (SAP or equivalent), Excel , and root cause analysis Familiarity with AQL standards , though not primary in QA, is a plus Proficiency in using QC lab instruments and interpreting test results Familiarity with Excel , ERP systems (SAP or equivalent) Knowledge of internal audits , root cause analysis , and process validation

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Quality Executive Contipro Industries

0.0 - 1.0 years

1 - 3 Lacs

Pune

Work from Office

Main Work and Duties * Performing Inspections * Performs inspections of raw materials, parts during production, and finished products as instructed by the Quality Engineer or Supervisor. * Uses basic measuring tools (like tape measures, calipers, etc.) accurately to check dimensions. * Follows clear checklists and procedures for each inspection. * Identifies obvious defects or problems and reports them immediately. * Documentation and Record Keeping * Fills out inspection reports neatly and accurately. * Helps maintain proper records of all quality checks and tests. * Organizes quality documents and ensures they are filed correctly. * Assists the Quality Engineer in preparing basic quality data and reports. * Supporting Quality Processes * Learns and understands the company's quality standards and procedures. * Helps in identifying products or parts that do not meet quality standards. * Assists in isolating and tagging non-conforming (defective) materials. * Supports the team in ensuring materials received from suppliers meet initial quality points on the Goods Received Note (GRN). Responsibilities: Conduct quality checks on incoming materials & outgoing products Ensure compliance with industry standards during production processes Perform in-process inspections for defects or deviations

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