GM QA CQA R&D

Ujjain - India

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Position: General Manager QA CQA R&D
Openings: 1
CTC Offered: Negotiable

Key Responsibilities:

Ensure all processes required for the Quality Management System (QMS) are effectively established implemented and maintained.
Report to the Executive Director on the performance of the QMS and identify areas requiring improvement.
Promote awareness of customer-specific requirements throughout the organization.
Act as a liaison with external stakeholders and regulatory bodies regarding QMS-related matters.
Oversee and guide New Product and Process Developments across the company.
Manage validation activities for processes systems and equipment.
Address and resolve market complaints in a timely and compliant manner.
Review and approve Standard Operating Procedures (SOPs) across all company locations.
Approve quality-critical documents including Change Controls Batch Manufacturing Records (BMR) and Deviations.
Plan and execute internal and external audits at all manufacturing and support sites.
Review and approve Corrective and Preventive Actions (CAPA).
Approve technical drawings and product specifications for consistency and compliance.
Manage Vendor Qualification Vendor Approvals and conduct Vendor Audits.
Oversee all Regulatory Affairs activities including:
- Registration of products in various international markets
- Timely submission and maintenance of annual regulatory updates
- Updating Drug Master Files (DMFs) for US Canada and China
Manage and coordinate ISO Certifications and CE Marking processes.
Approve Customer-specific Quality and Technical Agreements.

Qualifications & Skills:

Bachelors or Masters degree in Pharma Chemistry or a related field.
20 years of relevant experience in Quality Assurance Regulatory Affairs and R&D within the pharmaceutical healthcare or chemical industry.

Position: General Manager QA CQA R&D Openings: 1 CTC Offered: Negotiable Key Responsibilities: Ensure all processes required for the Quality Management System (QMS) are effectively established implemented and maintained. Report to the Executive Director on the performance of the QMS and identi...