Manager - Audit - US Good Manufacturing Practice

Job Title: Manager - US GMP Audit

Location: Mumbai, Delhi NCR

Job Type: Full-time

Experience Level: 6-10 years

Job Description:

We are looking for an experienced and proactive Manager for US GMP (Good Manufacturing Practice) Audits, with a strong preference for candidates who have a background in pharmaceutical companies. The ideal candidate will have 6-10 years of relevant experience, excellent client-facing skills, and the capability to lead and manage audit processes effectively.

Key Responsibilities:

US GMP Audit Management:

- Plan, coordinate, and execute US GMP audits for pharmaceutical products, ensuring compliance with regulatory standards and requirements.

- Develop audit strategies, schedules, and detailed plans, including timelines, resource allocation, and risk assessment.

- Conduct thorough pre-audit preparations, including documentation reviews, facility inspections, and staff training.

Regulatory Compliance:

- Stay updated with the latest US GMP regulations, guidelines, and industry best practices to ensure compliance.

- Interpret and communicate regulatory requirements to internal teams and stakeholders.

- Develop and implement corrective action plans to address audit findings and ensure continuous compliance.

Client Engagement:

- Serve as the primary point of contact for clients during audits, providing exceptional client service and maintaining strong professional relationships.

- Communicate audit findings, recommendations, and action plans to clients in a clear and concise manner.

- Provide ongoing support and guidance to clients in implementing corrective actions and maintaining compliance.

Team Leadership:

- Lead and mentor a team of audit professionals, providing guidance, training, and performance feedback.

- Foster a collaborative and high-performance team environment.

- Ensure the team's adherence to company policies, procedures, and ethical standards.

Continuous Improvement:

- Identify opportunities for process improvements and contribute to the development of best practices for US GMP audits.

- Implement and monitor key performance indicators (KPIs) to measure the effectiveness of audit processes.

- Participate in industry forums, workshops, and training programs to enhance professional knowledge and skills.

Qualifications:

- Bachelor's degree in a relevant field (e.g., Pharmaceutical Sciences, Quality Assurance, Regulatory Affairs, or related discipline).

- 6-10 years of experience in US GMP audits, preferably within the pharmaceutical industry.

- Strong understanding of US GMP regulations, guidelines, and compliance requirements.

- Proven experience in a client-facing role with excellent communication and interpersonal skills.

- Demonstrated leadership abilities, with experience in managing and mentoring teams.

- Strong analytical, problem-solving, and decision-making skills.

- Ability to work independently and handle multiple priorities in a fast-paced environment.

- Professional certifications related to regulatory affairs, quality assurance, or auditing (e.g., RAC, ASQ, CQA) are a plus.