Executive / Sr. Executive - QA (Market Compliance)

Aurobindo Pharma; Hyderabad, Jadcherla; On-site; INR 600,000 - 1,000,000; Full time

Job summary

A pharmaceutical company in Hyderabad is seeking an experienced Quality Assurance professional to ensure compliance with US FDA regulations and maintain quality systems. The ideal candidate will have 6-10 years of experience and a Bachelor's or Master's degree in Pharmacy. Responsibilities include developing protocols for regulatory compliance, conducting audits, and collaborating with teams to address compliance issues. This is an opportunity to contribute to maintaining high-quality standards in a leading firm.

Qualifications

• 6-10 years of experience in Quality Assurance or related field with expertise in Market Compliance (US FDA).
• Strong understanding of 21 CFR Part 820 regulations and familiarity with USFDA guidelines.

Responsibilities

• Ensure compliance with US FDA regulations through documentation review, audits, and inspections.
• Develop and maintain quality systems, procedures, and protocols for regulatory compliance.
• Collaborate with cross-functional teams to implement corrective actions and preventive measures (CAPA).
• Conduct risk assessments to identify potential hazards in marketed products.

Skills

Quality Assurance

Regulatory Compliance

Risk Assessment

CAPA

Education

Bachelor's degree in Pharmacy (B.Pharma)

Master's degree in Pharmacy (M.Pharma)

Job description

Roles and Responsibilities

• Ensure compliance with US FDA regulations, including 21 CFR Part 211, ICH Q10, through documentation review, audits, and inspections.
• Develop and maintain quality systems, procedures, and protocols for regulatory compliance.
• Collaborate with cross-functional teams to implement corrective actions and preventive measures (CAPA).
• Conduct risk assessments to identify potential hazards in marketed products and develop mitigation strategies.

Desired Candidate Profile

• 6-10 years of experience in Quality Assurance or related field with expertise in Market Compliance (US FDA).
• Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution.
• Strong understanding of 21 CFR Part 820 regulations and familiarity with USFDA guidelines.