Quality Assurance

Cosmos Group; Pune District; On-site; INR 300,000 - 360,000; Full time

Job summary

Cosmos Group is seeking a QA Executive in Pune with 2-5 years of experience in Quality Assurance, particularly in pharmaceuticals. Responsibilities include maintaining quality management systems, coordinating audits, and preparing compliance documentation. The role requires strong knowledge of ISO standards and a background in biology. The salary ranges from Rs. 300,000 to Rs. 360,000 per annum, with opportunities for professional development.

Qualifications

• 2-5 years of experience in Quality Assurance in the pharmaceutical industry.
• Strong understanding of ISO 13485 and regulatory requirements.
• Experience with audit compliance and QMS documentation.

Responsibilities

• Prepare and maintain QMS and technical documentation per ISO 13485.
• Coordinate internal and external audits and support compliance activities.
• Monitor validation and calibration schedules.

Skills

Audit - External

Audit - Internal

ISO

Medical Device

QA Validation

Quality Assurance

Education

Bachelor's in Biology

Job description

#### Quality AssuranceAdmore### ### **Roles & Responsibilities – QA Executive*** Prepare and maintain QMS and technical documentation as per ISO 13485 and MDR/CDSCO requirements* Support CE marking documentation and design dossier preparation for new products* Ensure implementation and maintenance of Quality Management Systems across manufacturing processes* Coordinate internal and external audits and support audit compliance activities* Maintain supplier records, batch records, and QA documentation* Review and issue BMR (Batch Manufacturing Records)* Handle deviations, CAPA, and root cause analysis for complaints and audit findings* Monitor validation, calibration, stability, bio burden, and fumigation schedules* Prepare and monitor process validation and machine validation activities* Coordinate with different departments regarding quality system requirements* Maintain QA records, QC reports, and document control activities* Support management review meetings by providing QA/QMS reports and records* Monitor implementation of corrective actions and system improvements* Support risk management analysis, post-market surveillance, and field safety corrective actions* Participate in continuous improvement and product development activities* Raise change notes and suggestions for process improvement* Conduct weekly verification and monitoring of departmental quality activities* Maintain stock and control of printed quality documents#### Admore---Gender: BothExperience: 2 - 5 YearsLocation: BAVALA-AHMEDABADSalary: Rs. 300000 - 360000 Lakhs Per AnnumKey Skill: Audit - External, Audit - Internal, ISO , Medical Device, QA Validation, Quality AssuranceQualification: BIOLOGYIndustry: Pharmaceuticals, Biopharmaceuticals, Bulk DrugsJob Function: Production / Maintance/ QualityRole: Quality Assurance- Location: PUNE- Location: AHMEDABAD- Location: AHMEDABAD- Location: AHMEDABAD- Location: PUNE