SME- Drug Device Combination Products
- Hyderabad
- Quality Assurance
- GMO
This vacancy has now expired. Please see similar roles below...
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 summary
The Subject Matter Expert (SME) for Drug-Device Combination Products will serve as a key resource within the organization for technical expertise and regulatory guidance related to the development, manufacturing, and commercialization of drug-device combination products. This position will play a critical role in ensuring compliance with relevant regulations, standards, and best practices governing the design, development, and lifecycle management of combination products.
Roles & Responsibilities:
- In-depth knowledge of regulatory standards and guidelines governing drug-device combination products, including FDA regulations (e.g., 21 CFR 211, 21 CFR 820 & 21 CFR Part 4), EU Medical Device Regulation (MDR), and International Organization for Standardization (ISO 13485) standards.
- Experience with regulatory submissions and interactions with regulatory agencies (e.g., FDA, EMA, MHRA, ANVISA).
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels of the organization.
- Strong analytical and problem-solving skills, with a focus on attention to detail and accuracy.
- Provide technical guidance and support for the development, testing, and manufacturing of drug-device combination products, including, compatibility testing, stability studies, and manufacturing process validation and cleaning Validation.
- Provide training and education to internal stakeholders on relevant regulations, standards, and best practices for drug-device combination products.
- Stay abreast of emerging trends, regulations, and technologies related to drug-device combination products. Identify opportunities for process improvements and enhancements to streamline development and regulatory processes.
- Familiar with the various tools of investigation, able to resolve the problem
- Demonstrate expertise in conducting thorough investigations, root cause analysis, and provide the solution.
B Pharmacy / M Pharm / M S c Pharmaceutical Technology
Minimum 15 to 17 years of experience in the sterile formulation manufacturing & IPQA and medical device industry with specific expertise in drug-device combination products (DDCP).
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/#!/
Latest jobs
Salary
Location
Ahmedabad
Type of Working
Full Time
Job Family
Sales General
Business Unit
GG INDIA
Location
Ahmedabad
Description
Job Summary We are seeking an experienced and dynamic individual to join our team as a Strategy Implementation and Market Development Manager. The ideal candidate will be responsible for implementing
Reference
8ac641ba-83a1-4ac6-983f-0a093114e74a
Expiry Date
01/01/0001
Salary
Location
Johannesburg
Type of Working
Full Time
Job Family
Field Sales - Primary/ RX
Business Unit
GG EM
Location
JOHANNESBURG
Description
The job incumbent will be responsible for the following within the GI and Respiratory Team Selling, detailing and promoting products, in a designated area, to targeted private sector clients.Assisti
Reference
0ea982e6-e8a2-4282-829f-21bd00160fba
Expiry Date
01/01/0001
Salary
Location
Mumbai
Type of Working
Full Time
Job Family
Product Marketing & Management
Business Unit
GG INDIA
Location
Mumbai
Description
Job Summary: We are seeking an experienced and strategic Launch Planning Manager to oversee the management of innovative pharmaceutical assets within Dr Reddy’s newly launched Incubation cluster.
Reference
78743f5b-be32-4d13-9fd6-a76241a338f7
Expiry Date
01/01/0001
Salary
Location
Baddi
Type of Working
Full Time
Job Family
Analytical R&D - OSD
Business Unit
IPDO
Location
Baddi
Description
Job Summary We are seeking a dynamic and experienced Analytical Scientist to ensure that products meet stringent quality standards, regulatory requirements, and are safe for public use. Your role wi
Reference
94b900ae-243c-477e-8cfd-b89932b097a8
Expiry Date
01/01/0001
Salary
Location
Chennai
Type of Working
Full Time
Job Family
Pharmacovigilance
Business Unit
GG INDIA
Location
Chennai
Years of experience
0 - 1
Description
Job SummaryWe are looking for the Primary scientific face of the organization to ‘Thought Leaders’ & physicians for a given therapy area. You will be responsible for Identification, mapping and profil
Reference
b95c8e4e-865f-4a2c-8858-2b22cb641f4f
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Production - Biosimilar (Drug Substance)
Business Unit
Biologics
Location
Hyderabad
Description
Job summaryWe are looking for an individual to execute downstream/upstream manufacturing unit operations, ensuring documentation and compliance within GMP (Good Manufacturing Practices), regulatory, a
Reference
4b49ce06-3efa-441b-ae85-d477eeba84b0
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Quality Assurance
Business Unit
GMO
Location
Hyderabad
Description
To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing.To Involve in valid O
Reference
c7e7994c-7252-414e-8052-051eb9aa5041
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Product Marketing & Management
Business Unit
GG INDIA
Location
Hyderabad
Description
Job Summary We are looking for dynamic and experienced Group Brand Manager responsible for identifying new product opportunities, developing business cases, and implementing positioning strategies wi
Reference
d4c5dac6-76fb-481a-b120-1aa2dfccba80
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Sales Training
Business Unit
GG INDIA
Location
Hyderabad
Description
Job SummaryWe are seeking an experienced and dynamic Sales Training Manager to lead the training agenda and enhance the overall performance of the sales field force." Roles & ResponsibilitiesConduct t
Reference
f369b5ff-4fe2-46ed-9bbe-b19752016698
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Production - OSD
Business Unit
GMO
Location
Pydibimavaram
Description
Job SummaryWe are looking for an individual to oversee day-to-day production operations, including guiding and coaching employees, ensuring equipment safety and maintenance, and executing batch manufa
Reference
3d2da1a5-9662-4031-819a-f30f3ae2af97
Expiry Date
01/01/0001
Jobs you have shown an interest in