Lead Associate, Quality Investigations

We are seeking an exceptional investigator to join us as Lead Associate Quality Investigations in our Princeton NJ office. This role will report to Lead Quality Systems. The Lead Associate Quality Investigations is responsible for conducting thorough investigations into qualityrelated issues ensuring compliance with regulatory requirements and driving continuous improvement in Quality Assurance processes. This role will serve as a key point of contact for internal and external groups supporting root cause analysis and corrective actions to maintain highquality standards.

Responsibilities: 

• Ensuresall Dr. Reddys NAGpartnerscomply with GMPs.

• EnsuresData Integrity and Data Review controlsand improvement effortsacross the North America region.

• Lead and conduct detailed quality investigation reviews and approvals related to deviations nonconformances and customer complaints.

• Reviews supports escalatesand approvescritical laboratoryand operationsinvestigations withpotentialto affectproduct availability. 

• ProvidesQuality support related to Analyticaland Operationsissues LaboratoryandManufacturing investigations Product Specifications Analytical Method Validation Process Validation Methodand processTransfer andmajorChange Controls for commercial and products under developmentare reviewed by QA in a timely manner. 

•  Perform root cause analysis using structured methodologies.

• Collaborate with internal crossfunctional teams and external business partners to develop and implement corrective and preventive actions (CAPAs) including batch disposition for qualityrelated issues.

•   Ensure compliance with industry regulations company policies and quality standards.

• Maintain accurate documentation of investigations and communicate findings effectively.

• Maintain the Partner Quality Index and capture internal KPIs.

• Trends escalatesissues toensure methodand product robustness based on monitoring of trend data. 

•  Reviews Analyticalmethodand processdevelopment enhancementsand validation/verification transfer related documentsandrawdata generated at DRL internaland contractorganizations.

• Support internal andexternal laboratoryand operationsAudits supplier quality management. 

•  Support audits and inspections by providing necessary documentation and responses.

•  Drive continuous improvement initiatives to enhance quality processes and minimize risks.

• Provide training and guidance to team members on investigation procedures and best practices.

Qualifications :

Educational qualification: Bachelors Degree (or its U.S. equivalent) in Life Sciences Pharmaceutical Sciences or a closely related field

Minimum work experience: 8 years of experience in a pharmaceutical and/or biotech

Skills & attributes: 

• Strong knowledge in pharmaceutical manufacturing and/or Laboratory techniques; especially Chromatography (HPLC GC) Dissolution and compendia test procedures.

• Strong knowledge of regulatory requirements (e.g. FDA GMP ISO).

• Proficiency in root cause analysis and problemsolving methodologies.

• Excellent communication documentation and analytical skills.

• Ability to work collaboratively in a fastpaced environment.

*Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future. 

Additional Information :

Our Work Culture

Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.

Equal Opportunity Employer 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion age sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against based on disability. 

For more details please visit our career website at Work :

No

Employment Type :

Fulltime