Specialist Clinical DQA
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Job Location:
Monthly Salary:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a detail-oriented Clinical Specialist DQA (Clinical Quality Assurance) to join our organisation in Hyderabad India. The successful candidate will be responsible for ensuring the integrity accuracy and reliability of our pre-clinical and clinical study conduct. Key responsibilities include:
- Plan and perform vendor qualification and audits for pre-clinical clinical and In-vitro studies service providers
- Post study audit (off-site and on-site) of Pre-clinical Bioequivalence studies and Clinical studies.
- Maintain and update the Quality Management System for Global Clinical Management
- Develop review and approve SOPs for pre-clinical clinical and QA processes
- Execute Clinical audit programs and support health authority inspections
- Review regulatory deficiencies and support cross-functional teams in preparing responses
- Analyse deviations incidents and root causes implementing corrective and preventive actions for clinical studies
- Self-Inspection of Global Clinical Management team
The ideal candidate will have a strong background in GCP GLP and quality management processes with the ability to work efficiently in a fast-paced environment.
Qualifications :
- Masters degree in Pharmacy or Clinical research
- 8-12 years of experience in clinical quality assurance or related field
- Strong proficiency GCP and GLP
- Hands-on experience with bioanalytical analysis
- Proven track record of working with large-scale data sets and data warehousing
- Excellent understanding of data governance principles
- Knowledge of current Regulatory updates and Inspections
- Strong analytical and problem-solving skills
- Attention to detail and ability to work efficiently in a fast-paced environment
- Excellent communication and collaboration skills
- Ability to work independently and as part of a team
- Strong organizational skills and ability to manage multiple projects simultaneously
Additional Information :
About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddys 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 1150 drug master files across key therapy areas such as Oncology Cardio-vascular Central Nervous System and Anti-Diabetes. The 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. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. 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.
For more details please visit our career website at
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Dr. Reddys Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Cant Wa ... View more
