Team Member - Documentation

Job Description

• Preparation, review and approval of of Standard Operating Procedures (SOPs).
• Preparation, review and approval  of various protocols and reports, including:
  • Confirmatory Batch Protocol
  • Hold Time Protocol
  • Process Evaluation (Pre-validation) Protocol
  • Trial Protocol
  • Process Performance Qualification/Validation Protocol
  • Stability Protocol
• Preparation of Master Production Records (MPRs) such as:
  • Master Formula Record (MFR)
  • Manufacturing Instructions (MI)
  • Production Order Raw Materials (PORM)
• Good process knowledge of OSD and semi solids  processes.
• Good Expert in MES - PASIX Design and troubleshooting 
• Designing of Master Batch Records (MBRs) in PASIX, ESP, GMBR, PVL, and PMBR based on MPR/PIS/MPC for new products as well as site transfer products, following SOPs and GMP requirements.
• Document circulation to cross-functional teams (CFT), follow-up for review, corrections, and approval.
• Creation and modification of Bill of Materials (BOM) and Recipes in SAP.
• Follow-up for BOM and Recipe-related tasks for Exhibit, Validation, and Commercial products.
• Creation of codes in SAP, such as:
  • Coated, Core, Blend, Enteric, Sub Coating and Drug Loading
• Creation of reservations in SAP.
• Inter and intra communication for sending BOM messages to CFTs.

Qualifications

B.Pharm/M.Pharm/M.Sc

MES Design Exposure good to have

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/