Section Head - QMS

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
We are seeking an experienced individual to lead our QMS team, overseeing compliance and all QMS related aspects. 

Roles & Responsibilities

. To review, maintain and implement change control management.

· Tracking and trending of CAPA for site and its verification of CAPA effectiveness.

· Handling of regulatory inspections and preparation of audit compliance reports.

· To review and approval of sampling protocols, validation protocols and reports.

· Responsible for review and tracking of technical agreements for the site.

· To involve in Preparation, Approval, Issuance and Retrieval of Documents.

· Responsible for assessment, review and tracking of vendor service agreements.

· To ensure preparation and approval of Annual Product Quality Reviews.

· Review of incident investigation reports and monitoring of CAPA arising from the incidents.

· To ensure adequate and timely review, approval of incident investigations and verification of the action plans.

· Review and approval of Site master file, Quality Manual and Validation Master Plan.

. To ensure reserve samples of finished products are maintained as per defined SOP.

· Ensure cGMP compliance at site.

· Responsible for ensuring quality and compliance wherever the GMP activities performed within the department and at the site.

· Responsible to escalate any non-compliance and quality defect identified during performing GMP activities and taking necessary notification and CAPA.

· Responsible for managing the documentation cell.

· Responsible for handling the queries from regulatory agencies.

· To involve and approve investigation of market complaints and provide suitable CAPA’s.

· Review & approval of Standard Operating Procedures.

· Review and approval of Master Manufacturing Documents.

· Approval of hold notes as per change control and blocking of material quantities in SAP as per approved hold notes.

· Responsible for ITQA activities.

· Review and approval of BOM.

· Review & approval of Tech packs & Dossiers.

· To review release/reject batch of finished drug product as per the procedures.

Educational qualification: B. Pharm or M. Pharm.

Minimum work experience: 12 to 15 years of experience

Skills & attributes:

Technical Skills
• Knowledge on OSD operations and processes.

• Knowledge on recent updates on guidance and expectations by regulators.

• Awareness on various pharmaceutical guidance such as 21CFR, ICH, SUPAC, etc.
• Hands on experience on statistical evaluation of data using Excel  or Minitab.
• Experience in concluding investigations by means of analytical thinking, logical reasoning and ensuring identification of correct RCA and effective CAPA implementation.
• Familiarity with audit compliance standards in the pharmaceutical industry.

Behavioral Skills
• Strong communication skill to co-ordinate with cross function team and regulatory/customer/internal audits and inspections.
• Leadership and team management skills to guide and lead the QMS team effectively.
• Safety and Quality conscious mind-set with a commitment to ensuring the safety of people, equipment, and facilities and ensuring compliance upkeep on shop floor.

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/#!/