QA/QC Executive

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.

* Strong 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.