Job Description

- Assistant Manager - Quality Assurance

Company:

Radicon Laboratories Ltd.

Experience:

8-10 years

Location:

Greater Noida

Position Overview:

Radicon Laboratories Ltd. is seeking a highly skilled and experienced

Assistant Manager - Quality Assurance

to oversee and ensure compliance with quality standards, regulatory requirements, and company SOPs. The ideal candidate will play a crucial role in maintaining product quality, driving continuous improvement, and ensuring adherence to GMP guidelines.

Key Responsibilities:

Quality Management System (QMS):

Implement and maintain QMS in compliance with regulatory requirements. Review and approve SOPs, deviations, change controls, CAPAs, and other quality documents.

Regulatory Compliance:

Ensure compliance with GMP, ISO, and other applicable regulatory standards. Prepare and support regulatory inspections and customer audits.

Documentation & Record Control:

Oversee preparation, review, and maintenance of quality documentation. Ensure timely approval and archiving of batch records, validation protocols, and reports.

Audits & Inspections:

Conduct internal audits and coordinate external audits. Address audit observations and implement corrective and preventive actions.

Training & Development:

Train and mentor the QA team on regulatory guidelines, SOPs, and best practices. Conduct periodic training sessions for employees on quality compliance.

Deviation & CAPA Management:

Investigate quality issues, deviations, and non-conformances. Implement corrective and preventive actions (CAPA) to mitigate risks.

Validation & Qualification:

Support process validation, equipment qualification, and method validation. Ensure compliance with validation master plans.

Supplier & Vendor Management:

Evaluate and approve suppliers/vendors for raw materials, packaging, and services. Conduct vendor audits and ensure supplier compliance.

Continuous Improvement Initiatives:

Identify areas for process improvement and implement best practices. Work closely with cross-functional teams to enhance overall quality performance.

Key Skills & Competencies:

Strong knowledge of GMP, ISO, and regulatory guidelines (USFDA, MHRA, WHO, etc.). Excellent documentation and compliance management skills. Experience in handling audits and regulatory inspections. Strong problem-solving, analytical, and decision-making abilities. Effective leadership, communication, and team management skills.

Qualifications:

Bachelor's/Master's degree in Pharmacy, Chemistry, Microbiology, or a related field. 8-10 years of experience in Quality Assurance within the pharmaceutical industry.

If you are a quality-driven professional with a keen eye for compliance and excellence, we invite you to apply and be a part of our growing team at Radicon Laboratories Ltd.

Job Type: Full-time

Pay: ?50,000.00 - ?70,000.00 per month

Benefits:

Health insurance Paid sick time Provident Fund
Application Question(s):

Current package??
Experience:

QA/QC: 6 years (Preferred) pharmaceutical manufacturing: 5 years (Required)
Work Location: In person