Job Overview The ISO Compliance & Documentation Executive will be responsible for maintaining and coordinating the company's ISO/QMS documentation and compliance activities. The candidate should be highly organized, detail-oriented, and capable of maintaining accurate records and documentation.

Candidates with experience in contact lens, ophthalmic products, medical devices, pharmaceutical, or other regulated manufacturing industries will be preferred.

### Key Responsibilities

#### 1. ISO & QMS Compliance

- Maintain and monitor day-to-day ISO/QMS compliance requirements.
- Ensure that required procedures, formats, records, and documents are properly maintained.
- Support implementation and maintenance of the company's Quality Management System.
- Ensure documentation is maintained as per applicable quality and regulatory requirements.
- Follow up with departments for timely completion of compliance-related activities.

#### 2. Documentation & Document Control
- Prepare, maintain, update, and control ISO/QMS documents.
- Maintain SOPs, work instructions, formats, registers, checklists, and quality records.
- Ensure the latest approved versions of documents are available to relevant departments.
- Maintain proper document numbering, revision control, and approval records.
- Maintain both physical and electronic documentation systems.
- Ensure proper filing, indexing, and retrieval of documents.

#### 3. Audit Coordination
- Assist in preparation for internal and external ISO audits.
- Maintain audit-related documents and records.
- Coordinate with concerned departments during audits.
- Track audit observations, non-conformities, and corrective actions.
- Maintain records of CAPA/NCR and follow up for timely closure.
- Ensure audit findings and corrective actions are properly documented.

#### 4. Quality Records
- Maintain production, inspection, testing,



and other quality-related records as applicable.
- Ensure records are complete, accurate, signed, dated, and properly filed.
- Review documentation for missing information or errors.
- Maintain compliance trackers and documentation status reports.

#### 5. Computer & Data Management
- Perform regular data entry and documentation activities.
- Maintain compliance and quality data in MS Excel.
- Prepare reports, trackers, and MIS as required.
- Maintain electronic records and folders in an organized manner.
- Use MS Word for preparing and formatting SOPs, reports, letters, and other documents.

#### 6. Coordination
- Coordinate with Production, Quality, QC, Stores, Purchase, and other departments for required documentation.
- Follow up for pending documents, records, approvals, and corrective actions.
- Provide documentation support to the Quality/Management team.
- Maintain confidentiality and accuracy of company records.

### Required Skills
- Strong knowledge of ISO compliance and documentation.
- Knowledge of QMS and document control.
- Good understanding of audit documentation and compliance processes.
- Knowledge of SOP preparation and maintenance.
- Good knowledge of CAPA, NCR, corrective and preventive actions.
- Strong MS Excel and MS Word skills.
- Good computer and data-entry skills.
- Excellent filing and record-management skills.
- Good communication and coordination skills.
- Solid attention to detail.
- Ability to work independently and manage documentation systematically.





### Preferred Experience

Candidates with experience in any of the following industries will be preferred:

- Contact Lens Manufacturing
- Ophthalmic Products
- Medical Devices
- Pharmaceutical Manufacturing
- Healthcare Products
- Laboratory / Diagnostic Products
- Other regulated manufacturing industries

### Educational Qualification
- Bachelor's degree in Science / Pharmacy / Life Sciences / Medical Devices / Quality / Engineering or a relevant discipline.
- Additional certification/training in ISO, QMS, Quality Assurance, or Medical Device Quality will be an advantage.

### Experience Required

Minimum 45 years of relevant experience in:

- ISO compliance
- Quality documentation
- QMS/document control
- Audit coordination
- Compliance documentation

Preference: Candidates having experience in ISO 13485 / Medical Device Quality Management Systems and contact lens/ophthalmic/pharmaceutical manufacturing.

### Key Performance Areas

- Accurate and timely ISO documentation
- Proper document control and filing
- Audit readiness
- Timely closure of audit observations
- Maintenance of quality records
- Compliance tracking
- Accurate data entry and reporting
- Effective coordination with internal departments

### Key Skills

ISO Compliance | ISO 13485 | QMS | Medical Device Quality | Documentation | Document Control | SOP | CAPA | NCR | Internal Audit | External Audit | Quality Records | Compliance | MS Excel | MS Word | Data Management

### Candidate Profile The ideal candidate should be organized, responsible, detail-oriented, computer-savvy, and capable of working independently. The candidate must be comfortable handling a large volume of documentation and should have the ability to follow up with different departments to ensure timely completion of compliance requirements.

📌 QA/QC Executive (New Delhi)
🏢 Proficient Amritsar
📍 New Delhi