SME - Global SOPs, Guidelines, Manual & Policies
SME - Global SOPs, Guidelines, Manual & Policies
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Job Description
- The Subject Matter Expert (SME) for Preparation of GMP documents (SOP Policy Guidance Manual etc.) related to various functions i.e. QA QC Mfg. WH Eng. IT etc.
- Taking the inputs with sites and Cross functions to evaluate and finalize the documents.
- Having the technical expertise in reviewing GMP documents for various functions considering the current GMP/Regulatory standards and the user feasibility.
- Having the thorough knowledge on Quality Management System elements i.e. Change control deviations market complaint OOS OOT product recall etc..
- Having the strong technical knowledge on the GMP guidelines related to API OSD Injectables processes.
- Exhibit strong communication and training skills.
- Identify opportunities for improvements evaluate and contribute to enhance the current processes in line with the updated current GMP processes and industry best practices in various processes.
- Capable of evaluating identified discrepancies at sites and providing resolution.
- Stay updated on industry trends and regulatory changes related to QMS.
- To be able to prepare the monthly Quality review reports and relevant data as per the requirement of management.
Qualifications :
B. Pharm / M. Pharm / M. Sc. Pharmaceutics with 15 years of experience.
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 stateoftheart 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 Cardiovascular Central Nervous System and AntiDiabetes. 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. 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 believe in the power of unity where diverse skills a common purpose and shared values spark magic
Who we areWe accelerate access to affordable and innovative medicines becauseGood Health Cant Wait! Watch...
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
