Assistant Manager QA

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