Senior Manager QA

Naukri Assist; Navi Mumbai; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Naukai Assist in Navi Mumbai, India seeks an experienced professional to oversee API manufacturing compliance, quality systems, and risk management. The role requires leading cross-functional improvements, implementing QMS-based controls, and driving regulatory audits to ensure adherence to cGMP and GMP standards.

The ideal candidate will have 11–15 years in the pharmaceutical industry, with a proven track record in risk mitigation within a regulated API environment.

Qualifications

• 11-15 years of experience in pharmaceutical industry, preferably in API manufacturing or related field.
• Strong understanding of cGMP compliance, GMP guidelines, and QMS principles.
• Proven track record of implementing effective risk management strategies in a regulated environment.

Responsibilities

• Ensure compliance with cGMP regulations, GMP guidelines, and QMS standards in the API manufacturing process.
• Develop and implement risk management strategies to mitigate potential risks associated with API production.
• Collaborate with cross-functional teams to identify areas for improvement and implement changes to optimize processes.
• Conduct regular audits and inspections to ensure adherence to regulatory requirements.

Skills

cGMP compliance

GMP guidelines

QMS principles

Risk management

Process improvement

Audit & compliance

Job description

Roles and Responsibilities :

• Ensure compliance with cGMP regulations, GMP guidelines, and QMS standards in the API manufacturing process.
• Develop and implement risk management strategies to mitigate potential risks associated with API production.
• Collaborate with cross-functional teams to identify areas for improvement and implement changes to optimize processes.
• Conduct regular audits and inspections to ensure adherence to regulatory requirements.

Job Requirements :

• 11-15 years of experience in pharmaceutical industry, preferably in API manufacturing or related field.
• Strong understanding of cGMP compliance, GMP guidelines, and QMS principles.
• Proven track record of implementing effective risk management strategies in a regulated environment.