Assistant Manager QA

2 days ago

Greater Noida, Uttar Pradesh, India Radicon laboratories ltd. Full time ₹ 6,00,000 - ₹ 12,00,000 per year

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, ₹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

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