Team Member - SIT (Injectables)

Job Summary
We are looking for an individual for the SIT Team to oversee the investigation , working closely with Cross-Functional Team (CFT) members to identify root causes and implement corrective and preventive actions. The role involves active participation in investigating Out of Specification (OOS) cases, deviation, market complaint .

Roles & Responsibilities
. You will be responsible for overseeing the investigation of OOS, OOT, deviation, market complaint , collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), preventive actions (PA), and preparing comprehensive reports.
. You will review investigation report providing constructive feedback for improvement.
. Your responsibilities include periodically assessing the trending of notification , highlighting or escalating key observations, regularly reviewing the dump to ensure accurate classification, and utilizing the Rubrics template for crafting investigation reports.
. You will offer necessary support to the site in readiness for or during regulatory inspections related to investigations.

Qualifications

Educational qualification: A Bachelor's or Master's degree in a relevant scientific field, such as Chemistry, Biochemistry, Pharmacy, or related discipline

Minimum work experience: 5 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance

Skills & attributes:

Technical Skills
. In-depth knowledge and experience in overseeing investigations, and familiarity with root cause analysis, corrective actions (CA), and preventive actions (PA).
. Expertise in investigating valid OOS and other relevant cases.
. Familiarity with reviewing SAP incident log and ability to perform classification of data.
. Ability to craft comprehensive investigation reports.
. Experience in providing necessary support for regulatory inspections related to investigations.
. Knowledge of regulatory requirements pertaining to incident investigations.

Behavioural Skills
. Ability to collaborate closely with CFT members.
. Analytical mind set for identifying root causes and developing effective solutions.
. Strong problem-solving skills and attention to detail in reviewing incidents, reports, and trending data and implementing corrective actions.
. Effective communication skills for report writing and escalation of key observations.
. Commitment to ensuring compliance with regulatory requirements in investigations.
. Ability to offer necessary support to the site in readiness for or during regulatory inspections.

Additional Information

About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such factories of the future is integral to innovation and to build healthcare of the future.

Benefits Offered
At Dr. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy's are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't 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 we're 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.
For more details, please visit our career website at https://careers.drreddys.com/#!/