Quality Auditor

Company Profile : Our client is European MNC involved in Imports Exports of Pharmaceutical & Medical Device. They have their Corporate office in Ahmedabad, Repacking plant in Kandla SEZ & H.Q. at Denmark

Position : Quality Auditor

Job Location : Ahmedabad

Job Purpose : In close coordination with Quality Director and audit team to perform

pre-qualification of manufacturers including document review and performance of on-site GMP/ISO 13485 audits as well as other QA tasks related to product and prequalification processes.

Job Responsibilities :

1. 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 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

Desired Profile :

• B.Pharm / M.Pharm with 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.

Competences: ·

• Updated on GXP concepts, WHO cGMP, EU GMP, ICH and PICS guidelines.
• Updated on ISO 9001 and ISO 13485.
• 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.
• Should be dedicated to follow core values.

Contact

Rina Arun