Assistant Manager - QA/QC

Role & responsibilities

Quality Assurance (QA)

• 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 ScienceOR 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