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Location

Andhra Pradesh | India

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Job 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

1.1 Adhere to the company policies and safety norms.

1.2 Adhere to the SOP’s and other laid down procedures in the production (Injectable area)

1.3 To coordinate with the superiors and other related departments for the smooth functioning.

1.4 To ensure the availability of man, machine and material to achieve the production plan.

1.5 Maintaining cGMP practices in production area.

1.6 To prepare/review GMP documents like SOP, BMR, Investigation report, risk assessment report, URS, qualification, validation, study protocols and reports etc.

1.7 To perform on- line entries in GMP documents like BMR’s, BPR’s, log-books etc. as per

Good Documentation Practice.

1.8 To ensure that all documents are updated/revised periodically to meet cGMP standards.

1.9 To perform all QMS related activities in production department.

1.10 To inform superiors in case of any incidents (Quality/safety).

1.11 Co-ordination with other related departments i.e. Ware house, Engineering, QA, QC, SHE, Administration, F&D, MSAT, CSV etc. for smooth functioning of department.

1.12 Supervision of the departmental activities.

1.13 Issuance, Receipt and submission of the BMR, BPR, log-books and other GMP records from QA for usage in department.

1.14 To do environmental monitoring of area as per respective SOP’s.

1.15 To follow the personnel hygiene practices.

1.16 To follow the good aseptic techniques in the critical area so as to assure the sterility of the products.

1.17 To maintain discipline in the department and to recommend action if any.

1.18 To ensure the preparation of the cleaning / disinfectant solution as per the schedule and respective SOP’s.

1.19 To ensure area/equipment cleaning and sanitization activities as per respective SOP’s.

1.20 To ensure area fumigation activities as per the schedule and respective SOP’s Operations & Documentation:

 

1.21 To ensure Operation & changeover of machines, their trouble shooting’s etc. as per respective SOP’s and instructions of superiors.

1.22 To ensure the up keep of the equipment, area and GMP records.

1.23 To ensure line clearance before related activities and make necessary entries in related documents.

1.24 To participate in dispensing and receipt of materials from warehouse/stores.

1.25 To participate in routine production activities as per instructions of superiors.

1.26 To ensure for activities like unit preparation, GMP washing, filter integrity testing, steam sterilization, CIP, SIP, compounding and related documentation for the same by manually or MES.

1.27 To ensure activities like Sterilization glove integrity, VHP (Vaporized hydrogen peroxide) cycle, isolator integrity, aseptic assembling, filtration, vial washing, depyrogenation, filling/sealing, Lyo loading/unloading, external decontamination etc. and related Documents by manually or MES.

1.28 To ensure equipment operation like lyophilization, visual inspection, labeling & Packaging etc. and related Documents by manually or MES.

1.29 To ensure that yield of the product at respective stage of batch processing is within the specified limits.

1.30 Reconciliation of the materials, in-process and final products etc.

1.31 Participation in media fill as per the schedule.

1.32 To raise the breakdown requests in SAP and inform to all concerned person.

1.33 To raise analysis requests and coordinate with QC for test results.

1.34 To do process entries in SAP.

1.35 To participate in inspections (Internal/External).

1.36 To maintain and follow the safety precautions to avoid accidents in the production department and to inform superiors in case of any incidents.

1.37 To undergo training as per the matrix and to train the production personnel on their routine work.

1.38 To perform any other task/project assigned by Head Operations

1.39 Preparation of MFR and PORM.

1.40 Follow up for BOM and recipe approvals.

1.41 Creation of Bill of Materials and Recipes in SAP.

1.42 Modification of Bill of Materials and Recipes.

1.43 Designing of MBR’s based on the CB report, Product Information Sheet, & PORM for new products as well as site transfer products.

1.44 Designing MBR as per process, formulations and PAS-X system required.

1.45 Designing MBR’s by fallowing the standard operating procedures and GMP requirements.

1.46 Manufacturing order (MO) creation in PAS-X Quality server.

1.47 Interaction with Production, Ware house and designing MBR as per requirement for creating efficient MBR’s.

1.48 Follow ups with CFT’s and PAS-X administrator resolving issue related to MBR.

1.49 Creation of MBR Libraries considering the product process requirement and parameterization.

1.50 Identification of problem during real time execution of batches and rectification of MBR related issues.

1.51 Designing of GBMR, PVL, PMBR & MBR based on the MPC / Data sheet for new products as well as site transfer products.

1.52 Manufacturing order (MO) creation in PAS-X Quality server

1.53 Interaction with Production, Ware house and designing of packing MBR as per requirement for creating efficient MBR’s.

1.54 Follow ups with CFT’s and PAS-X administrator resolving issue related to GMBR,PVL,PMBR & MBR.

Qualifications

Educational qualification: A Bachelor's or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, or Diploma Mechinical, 

Minimum work experience : 4-6 years of experience in pharmaceutical manufacturing operations, with a focus on batch manufacturing, and process validation

Skills & attributes:

Technical Skills
• Expertise in line operations, especially in manufacturing activities like CIP, SIP, and batch manufacturing.
• Proficiency in understanding equipment such as Steam Sterilizer, Dry heat sterilizer, HVAC, water system, compressed air, Nitrogen system, etc.
• Understanding of Process Validation for Sterilization, Washing, Aseptic filling, and cleaning procedures.
• Knowledge for evaluation of change control, deviation, incident, out of specification, out of trend, and risk management.
• Experience in preparing production process SOPs and batch records.
• Understanding and application of Aseptic processes, Lean, OEE, and similar KPIs.
• Hands-on experience in regulatory audits, particularly with agencies like the US FDA.

Behavioural Skills
• Capacity to provide training on good manufacturing practices and other relevant areas.
• Demonstrates a proactive approach to identifying and solving challenges in manufacturing processes.
• Exhibits a keen attention to detail in handling complex manufacturing activities, ensuring precision and accuracy.
• Collaborates seamlessly with cross-functional teams, promoting a cooperative and inclusive work environment.
• Efficiently manages time to meet production schedules and deadlines without compromising quality.
• Displays a willingness to stay updated on industry trends, regulations, and emerging technologies, contributing to ongoing professional development.
• Knowledge of working in regulatory environment like USFDA, MHRA, TGA.
• Should have good understanding of cGM, cGDP, and good laboratories practice.
• Must have hands-on experience in sophisticated manufacturing machine and equipment.
• Effective communication and training skills for user departments and service providers.

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  

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