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04/01 Rina Arun
Team Leader at United HR Solutions Pvt. Ltd.

Views:177 Applications:10 Rec. Actions:Recruiter Actions:3

Quality Auditor - Medical Device (10-17 yrs)

Ahmedabad Job Code: 30212

Desired Profile : B.Pharm / M.Pharm + Certified International GMP auditor.

- ISO 9001, ISO 13485, ISO 14001 certified auditor.

Work experience :

- 10 years on hands experience from production, QC and QA of manufacturers of sterile and oral finished dosage forms for the international markets.

- Knowledge of water, air handling and ventilation systems.

- Knowledge of process and cleaning validation.

- 5 Years Quality Auditor Experience from Asia, Africa, and China.

- Audit experience of Sterile Manufacturing Plants, General Pharmaceutical Manufacturing Plants, Medical Devices and IVD's.

Competences :

- Updated on GXP concepts, WHO cGMP, EU GMP, and ICH guidelines.

- Updated on ISO 9001, ISO 13485 and ISO 14001.

- Good oral communication skills with an ability to explain and justify audit findings in a simple, respectful, and understandable manner.

- Good written communication skills with clear structured closure of all conclusions.

- Well structured, detail oriented, strong coordinator with decision making capabilities.

- Understand and be oriented towards use of ERP system, share point as a tool and use it efficiently within own area of work.

- Active and proactive in everyday issues with a solution-oriented mindset.

- Good with time management, prioritization, and meeting deadlines.

- Team player and a team builder to ensure an efficient process.

- Self-confident personality, with high ethics and morality.

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