Section Head - Quality Assurance
- 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.
- Investigation of OOS, OOT & Incidents
- Ensuring CAPA implementation and effectiveness.
- Handling of customer and support in regulatory audits.
- Review and approving of validation and qualification protocols & reports.
- Handling of market complaints and review of associated investigations, ensuring the timely closure of the complaints.
- Handling to return goods, review of associated investigations and ensuring appropriate closure of the return goods.
- Handling of product recall and mock recalls as per schedule
- Review and approval of change notifications.
- Carrying assigned Self-inspection as per the schedule and ensure its correction, corrective and preventive actions are taken.
- Review and approval of quality risk assessments.
- Ensure training activities are carried out as per SOP
- Monitoring and ensuring CQT activities and regulatory submissions
- Review of SOPs
- Monitor the team activities
- Review and approval of CAPA, OOS, Incidents trends
- Coordination for the site level quality management review and preparation of data for the QRM meetings and escalation of quality concerns as identified with Site Leadership team.
- Handling of vendor qualification.
- Complete the self-training and monitor the training of team members on relevant SOPs.
- Review of Annual Review Reports.
- Authorized for approval of phase 1/ 2 & LIMS task w.r.t OOS/OOT/hypothesis study/reanalysis / retesting /resample, once relevant investigation approved by QA Head or Quality Head.
- Authorized for approval of validation protocols, reports, SOPs and specifications in absence of QA head/ Quality head or based on instructions from QA head/ Quality head.
- Any other responsibility as assigned by HOD
Educational qualification: A Graduate or Postgraduate in pharmaceutical science
Minimum work experience: 12 years of experience in QA in pharmaceutical industry, preferably with shop floor experience
Skills & attributes:
Technical Skills
- Thorough understanding of the pharmaceutical industry, including its regulatory framework, quality standards, and market dynamics.
- Knowledge of regulatory requirements for pharmaceutical manufacturing processes, like technology transfer, manufacturing, and commercialization.
- Familiarity with international regulatory guidelines established by the International Council for Harmonization (ICH).
- Ability to interpret and apply ICH guidelines related to drug development, including those concerning quality, safety, efficacy, and regulatory submissions.
- Proficiency in quality management systems, validations (process, cleaning), audits handling, response drafting.
Behavioral skills
• Proficient in effectively allocating and utilizing resources to optimize productivity and achieve goals.
• Strong leadership qualities to inspire and motivate team members towards common objectives, fostering collaboration and innovation.
• Capable of efficiently managing time to prioritize tasks, meet deadlines, and maintain productivity levels.
• Possesses excellent verbal and written communication skills to convey ideas, instructions, and information clearly and effectively.
• Analytical thinking to assess situations, identify problems, and develop strategic solutions, contributing to informed decision-making processes.
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
Princeton
Type of Working
Full Time
Job Family
Product Marketing & Management
Business Unit
NAG
Location
Princeton
Description
We are seeking a Lead Associate Marketing SRx (Specialty generic injectables) to develop and implement marketing and sales strategies for assigned products, develop annual budgets and latest estimates
Reference
40223d68-4e78-4215-b2c9-3e7c3c342338
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Analytical R&D - Parenteral
Business Unit
IPDO
Location
Hyderabad
Description
Job Summary We are seeking a highly skilled Analytical Scientist in to join our Research and Development team for Injectable Division for developing and validating analytical methods for injectable
Reference
b8424494-4ad3-4634-b1c6-a08026d2419e
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Operation, Repair & Maintenance
Business Unit
GMO
Location
Pydibimavaram
Description
Job Summary Roles & Responsibilities:Hands on experience of Overall Asset care for Process equipment to take care of the total process equipment health of the plant.For OSD/Encapsulation/Ointment/QCOS
Reference
d2681c38-6aa2-4623-83c8-868131302758
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Operation, Repair & Maintenance
Business Unit
GMO
Location
Pydibimavaram
Description
Job SummaryWe are looking for an Electrical or Instrumentation engineer and areas of responsibilities are Utility Operations and Maintenance, Maintenance of Utility equipment, Inventory Control, Execu
Reference
0d890c28-a87f-4ac7-9775-9c1d55a0b6ac
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Technology Transfer - OSD
Business Unit
IPDO
Location
Pydibimavaram
Years of experience
12 - 20
Description
We are seeking a dynamic and experienced Team leader for our Manufacturing Science and Technology (MSAT) department in Pydibimavaram, India. This key leadership role will drive process optimization, t
Reference
22d8bbfe-334b-49b6-bc79-0ac6033f5868
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Formulation R&D - OSD
Business Unit
IPDO
Location
Hyderabad
Description
Job Summary We are seeking a dynamic and experienced Scientist Process Development in the pharmaceutical development process, responsible for formulation understanding, process design, optimization,
Reference
175f1722-0648-4c56-93d6-afb3973cdbd8
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Production - OSD
Business Unit
GMO
Location
Pydibimavaram
Description
Roles & ResponsibilitiesEnsuring effective implementation of company policies and procedure at production department.Ensuring that products are produced as per cGMP practices and stored in cGMP compli
Reference
b9a055ca-eafe-4601-8a25-32afa128bc13
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Quality Assurance
Business Unit
GMO
Location
Hyderabad
Description
Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control.Review and usage decision of analytical reports in LIMS, Empower and SAP.Electronic signature
Reference
332e9b3b-6e40-4d2c-88f2-192b877f0e98
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Operation, Repair & Maintenance
Business Unit
GMO
Location
Pydibimavaram
Description
Job Summary Roles & Responsibilities:1. Hands on experience of Overall Asset care for Process equipment to take care of the total process equipment health of the plant. For OSD/Encapsulation/Ointment/
Reference
1c72a34a-7672-4828-86ac-6169361fbf87
Expiry Date
01/01/0001
Salary
Location
Mumbai
Type of Working
Full Time
Job Family
Sales General
Business Unit
GG INDIA
Location
Mumbai
Description
Trade HeadPosition SummaryAs a Trade Head for the DRL – Nestle JV ,the incumbent will be responsible for developing and executing effective trade strategies to setup distribution, maximize revenue, an
Reference
8e27c658-0467-4d78-9d26-7eb3c2b59779
Expiry Date
01/01/0001
Jobs you have shown an interest in