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Quality Auditor
Location:
Ahmedabad, Gujarat
Description:
Client's Company Profile: Our client provide healthcare solutions i.e. Generic Products, Medical Devices / Consumables . They are headquartered at Denmark and regional offices in Africa, India, China, Europe and local representation all over the world. Job Profile: The position would be responsible for Proactive coordination of audits to ensure compliance to prequalification criteria of manufacturer and products. 2. Closely monitoring of audit frequency and follow up audit to ensure continued approval of prequalified manufacturers. 3. Prepare audit agenda, coordinate, and ensure that the relevant site and product documentation from manufacturers is assessed following agreed criteria and process. 4. Conduct and report on-site GMP audits including follow up on audit compliance, verification of needed corrective actions and conductance of compliance-audits. 5. Ensure timely documentation of audits in ERP system and share- point. 6. Participate in Audit Team meetings, coordinate with audit team members and Quality Director. 7. Active part in developing manufacturers enabling compliance to present GMP, ISO and Missionpharma requirements. 8. Dedicated in development of SOPs and processes related to product and site pre-qualification. 9. Involvement in root/cause activities for product deviation, claims or any other quality issues related to a manufacturer. 10. Responsible for manufacturer related strategic development projects. 11. Active part in assessment, guiding QA for approval of products and pre-qualification activity. Work experience: + 10 years on hands experience from QA, QC and Corporate 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, Europe, US and other ROW market Audit experience of Sterile Manufacturing Plants, General Pharmaceutical Manufacturing Plants, Medical Devices and IVD’s. Education: Bachelor/Master degree of Pharmacy or Pharmaceutical Science. Contact Person: Rina Arun / Srushti Raval XXXX@uhr.co.in 989887XXXX
Posted:
March 19 on iSmartRecruit
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More About this Listing: Quality Auditor
Quality Auditor is a Quality Assurance Quality Auditor Job located in Ahmedabad GJ. Find other listings like Quality Auditor by searching Oodle for Quality Assurance Quality Auditor Jobs.
Quality Auditor is a Quality Assurance Quality Auditor Job located in Ahmedabad GJ. Find other listings like Quality Auditor by searching Oodle for Quality Assurance Quality Auditor Jobs.