Lead Quality Specialist - Investigator

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

Role Description:

• The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.
• This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.
• Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.

Scope of Authority

• Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.

Responsibilities;

1. Initiation, Execution, and Closure of QC Lab Investigations (60%)

• Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.
• Provide support and guidance to QC teams during execution, writing, and closure of investigations.
• Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.
• Utilize laboratory software for root cause and impact analyses.
• Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.
• Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.

2. Corrective and Preventive Actions (CAPAs) (30%)

• Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.
• Assist with training, procedure updates, and monograph revisions based on investigation outcomes.
• Provide recommendations for process improvements to support continuous improvement initiatives.

3. Compliance (10%)

• Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.
• Provide compliance expertise, training, and support to QC and other impacted departments.

Requirements:

Education & Experience

• Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.
• Minimum of 4 years of experience in a pharmaceutical manufacturing environment.

Knowledge

• Proficiency in HPLC, GC, and related chromatography methods and equipment.
• Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.
• Comprehensive understanding of QC lab testing and data integrity principles.
• Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).

Skills & Abilities

• Strong technical writing and documentation skills.
• Problem-solving and decision-making expertise.
• Excellent communication skills with peers, chemists, and senior management.
• Critical thinking and root cause analysis proficiency.
• Customer and stakeholder focus, with a strong commitment to quality and integrity.
• Physical & Mental Requirements
• Ability to sit, stand, walk, and use a computer for extended periods.
• Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.
• Ability to wear personal protective equipment (e.g., gloves, respirators).
• Specific vision requirements include close vision and color vision.