Lead Site Investigation Team

Job Summary
We are looking for someone who can Lead performing investigations related to Biologics Drug Substance Manufacturing ensuring thorough root cause analysis and implementation of CAPA crucial for maintaining product quality and compliance. The role involves reviewing incident reports related to Drug Substance Manufacturing for Biologics collaborating with cross-functional teams and providing mentorship to cross function to enhance investigation and reporting capabilities ultimately fostering a culture of continuous improvement and regulatory compliance within the organization.

Roles & Responsibilities
You will be responsible for leading investigations related to Biologics Drug Substance Manufacturing valid OOS (Out of specification) cases and other relevant incidents collaborating closely with SIT (Site Investigation Team) members site CFT (Cross-functional Teams) and operating staff to determine root cause corrective actions (CA) and preventive actions (PA) ensuring unbiased and objective closure with high confidentiality.
You will review Drug substance related incidents provide improvement feedback and periodically assess  incident trends highlighting key observations.
You will review incident-related reports and logs ensuring proper classification and notifying management of findings.
You will be responsible for using defined template for investigation report writing and provide support to sites during regulatory inspections.
You will participate in internal/external audits and contribute actively to site review meetings from drug substance unit.
You will facilitate the development of site CFT members investigation and report writing skills setting up a review and governance mechanism for SIT at the site.
You will be responsible for presenting periodic updates on key findings open issues fostering strong connections between SIT Cross functional team members MSAT (Manufacturing Science and Technology) members and key stakeholders of Drug Substance unit

Qualifications :

Qualifications

Educational qualification: . or . or . 
Minimum work experience: 8 to 10 years

Skills & attributes:
Technical Skills
Experience in handling OOS and investigations related to biologics drug substance manufacturing root cause analysis CA and PA.
Proficiency in leading investigations and applying RCA methodologies to identify underlying causes accurately.
Experience in utilizing incident management systems classify and manage incidents effectively ensuring proper documentation and notification of findings to management.
Understanding of regulatory requirements related to incident investigation and reporting including familiarity with KPI for investigation report writing and support during regulatory inspections.
Experience in participating in internal and external audits providing support in investigation-related matters and ensuring compliance with audit requirements and standards.
Capacity to facilitate skill development in root cause analysis and report writing and establish governance mechanisms to ensure the quality and consistency of investigations across the site.

Behavioural skills
Good writing skills for preparing investigation report and technical reports.
Strong collaborative skills to work closely with SIT members site CFT and management fostering teamwork.
Excellent communication skills to convey complex technical information clearly and concisely.
Demonstrated  abilities to lead investigations collaboratively work with team members and facilitate skill development inspiring confidence and trust in the investigation process and outcomes.
Critical thinking and analytical skills to analyse deviation-related data identify patterns and trends and draw meaningful insights

Additional Information :

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year time horizon...

Benefits Offered

At Dr. Reddys we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddys are on par with the best industry standards...

 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...

For more details please visit our career website at Work :

No

Employment Type :

Full-time