Team Leader at United HR Solutions Pvt. Ltd.
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Quality Auditor - Medical Device (10-17 yrs)
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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