MSAT- Investigation Lead

4 days ago

Pune, Maharashtra, India Enzene Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Role & responsibilities:

  1. Lead investigations into quality incidents, deviations, and non-conformances within our manufacturing processes.

  2. Conduct thorough root cause analyses to identify the underlying causes of quality issues and develop effective corrective and preventive actions (CAPAs).

  3. Collaborate closely with cross-functional teams, including production, engineering, and quality control, to drive investigations to resolution.

  4. Utilize scientific and statistical methodologies to support investigations and determine appropriate corrective actions.

  5. Provide technical expertise and guidance to junior investigators and ensure investigations are conducted in compliance with regulatory requirements and company policies.

  6. Develop and implement strategies to prevent recurrence of quality incidents, leveraging best practices and industry standards.

  7. Monitor and report on investigation progress, ensuring timely completion and documentation of investigation activities.

  8. Continuously improve investigation processes, tools, and systems to enhance efficiency and effectiveness.

Preferred candidate profile:

  1. Proven experience in a manufacturing or MSAT role within the pharmaceutical or biotechnology industry.

  2. Demonstrated expertise in conducting investigations, root cause analysis, and implementing effective CAPAs.

  3. Thorough understanding of Quality Management Systems (QMS) and regulatory requirements, including FDA guidelines and cGMP.

  4. Strong analytical and problem-solving skills, with the ability to apply scientific methodologies to complex quality issues.

  5. Excellent communication and interpersonal skills to collaborate with multidisciplinary teams and effectively communicate investigation findings and recommendations.

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