Investigation Lead - Pharmaceutical OSD - Pune

Job Title:

Location:

Job Summary:

Key Responsibilities:

1. Lead and Oversee Investigations

1. Direct and manage investigations into deviations, non-conformances, product complaints, and other quality issues.
2. Ensure that investigations are thoroughly conducted, and root causes are identified using structured methodologies (e.g., Root Cause Analysis, 5 Whys, Fishbone diagrams).
3. Coordinate with cross-functional teams including Quality Assurance, Production, R&D, Regulatory Affairs, and others to ensure timely and effective investigation outcomes.

2. Develop and Implement Investigation Strategies

1. Establish and execute investigation strategies for critical quality issues and ensure adherence to timelines and objectives.
2. Prioritize investigations based on their impact on product quality, regulatory compliance, and patient safety.

3. Root Cause Analysis and Corrective Actions

1. Lead detailed root cause analysis and implement Corrective and Preventive Actions (CAPAs) based on investigation results.
2. Drive the development of CAPA plans to address both short-term containment and long-term systemic improvements.
3. Monitor the effectiveness of CAPA implementation and ensure closure in compliance with quality management systems.

4. Regulatory Compliance and Reporting

1. Ensure investigations comply with GMP, regulatory guidelines (FDA, EMA), and internal quality standards.
2. Prepare and submit detailed investigation reports to regulatory authorities as required.
3. Coordinate and lead responses to regulatory inspections and audits related to investigations.

5. Risk Management and Mitigation

1. Conduct risk assessments to evaluate the potential impact of quality deviations on product safety and regulatory compliance.
2. Work with risk management teams to identify, assess, and mitigate risks related to manufacturing processes and quality deviations.

6. Data Analysis and Continuous Improvement

1. Use data analytics to identify trends and potential issues, providing proactive solutions to prevent future investigations.
2. Lead initiatives to drive continuous improvement in investigation processes and overall quality systems.
3. Foster a culture of quality excellence by promoting knowledge-sharing, best practices, and lessons learned from investigations.

7. Stakeholder Communication

1. Provide regular updates to senior leadership on investigation progress, corrective actions, and potential risks.
2. Communicate investigation outcomes clearly to internal and external stakeholders, ensuring transparency and alignment with organizational goals.

8. Training and Development

1. Mentor and train junior team members on investigation methodologies, regulatory compliance, and root cause analysis techniques.
2. Develop and implement training programs to ensure the team stays updated on the latest investigation tools, industry standards, and regulatory requirements.

c. External Engagement and Industry Benchmarking

1. Stay informed about industry trends, best practices, and regulatory changes by participating in industry forums and conferences.
2. Conduct benchmarking to ensure that the companys investigation practices align with industry standards.

Qualifications

1. Bachelors or Master’s degree in Pharmacy, Chemistry, or a related field.

2. Additional certifications in Quality Assurance, GMP, or Regulatory Affairs (preferred).

3. Minimum of 15 years of experience in the pharmaceutical industry, with at least 5 years in a leadership role within quality assurance or investigations.

4. Proven experience in managing and leading complex investigations, corrective actions, and risk assessments.

5. Strong understanding of regulatory requirements (FDA, EMA), Good Manufacturing Practices (GMP), and industry standards.

Skills:

1. Expertise in Root Cause Analysis (RCA), failure investigation methodologies, and CAPA development.

2. Strong analytical and problem-solving abilities, with a data-driven approach to decision-making.

3. Excellent communication and presentation skills, with the ability to clearly report and communicate findings to senior management and regulatory bodies.

4. Experience working with cross-functional teams and managing multiple projects simultaneously.

5. Proficiency in quality management systems (QMS) and regulatory compliance systems.

Personal Attributes:

1. Strong leadership and team management capabilities.

2. Ability to work under pressure and manage tight deadlines.

3. Detail-oriented with a strong focus on quality and compliance.

4. Proactive, self-motivated, and able to drive continuous improvement.

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