Team Member - Documentation at Dr Reddy's Laboratories Limited

, Andhra Pradesh, India -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

0.0

Posted On

06 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SOP Preparation, Protocol Development, Master Production Records, OSD Processes, Semi Solids Processes, MES PASIX, MBR Design, SAP BOM, SAP Recipes, GMP Requirements, Document Control, Process Validation

Industry

Pharmaceutical Manufacturing

Description

Company Description Dr. Reddy’s 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 Can’t Wait. We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). ‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization. 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/ Job Family: Quality Sub Job Family: Quality General Preferred type of working: On-Premise Years of Experience: 3 - 6 Business unit: GMO

Responsibilities

Responsible for the preparation, review, and approval of SOPs, protocols, and Master Production Records. Manages the design of Master Batch Records in PASIX and handles BOM and recipe modifications within SAP.