Designation Manager - QUALITY compliance (QMS)

Educational Qualification(Required) M Pharm/ M Sc.

Experience(Required) Pharma background & QMS tools exposure with high environment of Regulated market and compliance set up involvement

Quality System and Compliance within the Quality Management System (QMS) using various QMS assessment tools

Role Purpose Focused functional deployment on Quality compliance QMS activities RCA, CAPA, NCS, Maturity assessment, Quality tools, technical assessment & Regulatory audits Regular Gemba findings review to assess proactively for any Gaps in present quality systems, Risk assessment in major failure, findings and or customer complaint preparation updation and Life cycle management of Site Master file, Quality Manual, QMS SOPs and execution with effectiveness check of QMS through trend analysis Lead audit and compliance activities, audit report finding based action plan follow up and closures

Technical Skills & Knowledge - Requirement

1) Should be well versed with the QA / QC function as applicable in Soaps & PCP area.

2) Should be able to provide inputs towards improving the existing systems based on the business requirements

3) Should be capable of interacting with all manufacturing locations and with Customers.

4) Should have good analytical and problem solving skills

Key Responsibilities :

1. Introduce a culture of Risk Management supported by policies and guidance leading high quality culture.

2. Ensure that all systems, processes and documentation will meet the pre-qualification questionnaire and are in compliance with various quality standards and regulations

3. Maintain the Quality manual, & Quality system SOPs and all compliance procedure documentation updated.

4. Lead the compliance risk assessment process, Impact analysis ensuring that the compliance risks are appropriately identified and assessed.

5. Implement, support and audit relevant quality assurance systems across the organisation.

6. Review compliance policies and procedures on a regular basis to ensure they comply with statutory and regulatory requirements.

7. Adopt and maintain awareness and understanding of quality/regulatory compliance requirements across the organization and create a culture of quality in the company

8. Represent company during client visits, audits and regulatory agency inspections demonstrating high quality culture 9. Monitor and evaluate performance against standards, use audits feedback loops and corrective action to ensure continuous improvement. Prioritise and escalate issues resulting in non-compliance

10. Create action plans which show how these policies and plans will be implemented and undertake regular audits to demonstrate that they are effective

11. To handle complaints received and perform failure investigation with root cause analysis, CAPA and effectiveness of CAPA.

12. Collate, evaluate data and identify areas for improvements. Evolve/recommend and implement remedial actions, follow PDCA (Plan, Do, Check, Analyse) cycle and monitor effectiveness.

13. Training cross functional QA teams on Quality Tools like Quality Circles, Kaizen etc.

14. Follow and implement ISO Quality Management System and ISO 22716 quality system in spirit.

15. Create Quality awareness across functions and design tools to enhance quality performance.

Interested candidates having relevant experience can share their profiles

Trupti

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