DQA Associate
- Dr Reddys
- 3 - 6 years
- Hyderabad
- 7 days ago
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Job Description
Job Summary
We are looking for an individual for the Quality Assurance team to review and revise SOPs, oversee document control in product development, and conduct risk assessments. Responsibilities include reviewing specifications and STPs, ensuring data integrity, proposing QbD (Quality by Design) process changes, and participating in phase gate reviews.Roles & Responsibilities
You will be responsible for reviewing and revising SOPs (Standard Operating Procedures), obtaining supervisor approval for system-related revisions, and communicating SOP changes to all High-Performance Teams (HPTs).
Your role involves the preparation, review, approval, and control of documents generated during product development.
You will conduct, review, and approve risk assessments throughout the product development process.
You will review and approve specifications and Standard Testing Protocols (STPs) for various materials at different development stages, ensuring compliance with guidelines and SOPs during all stages of development and technology transfer.
Your responsibilities include exercising control over data integrity, checking documentation and product development reports related to filings, and participating in proposing Quality by Design (QbD) process changes.
You will also conduct, review, and approve phase gates for drug products in coordination with development, and conduct self-inspections at the Integrated Product Development Organization (IPDO) according to the schedule.
You will be responsible for ensuring compliance in development laboratories, reviewing and approving facility/equipment qualifications at IPDO, and managing Quality notifications such as incidents and change controls through the Quality management system.
Educational qualification: A Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or a related field; advanced degree in Pharmaceutical Sciences or Regulatory Affairs is advantageousMinimum work experience: 5-7 years of experience in the pharmaceutical industry, with a focus on product development and quality managementSkills & attributes:
Technical Skills
Thorough understanding and practical application of regulatory requirements in pharmaceutical development.
Proficient in implementing Quality by Design (QbD) principles in the product development process.
Experience in reviewing, revising, and managing SOPs in alignment with industry standards.
Expertise in conducting, reviewing, and approving risk assessments throughout the product development lifecycle.
Strong focus on ensuring data integrity and compliance with documentation standards.
Behavioural skills
Effective communication skills to relay SOP changes and ensure understanding across cross-functional teams.
Meticulous attention to detail for reviewing specifications, STPs, and development reports to maintain data integrity.
Ability to adapt to changes in the development process and propose improvements in the QbD approach.
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. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say, because Good Health Cant 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 were 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 Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Healthcare & Life SciencesRole Category: NursingRole: Associate Nurse Unit ManagerEmployement Type: Full timeContact Details:
Company: Dr ReddysLocation(s): Hyderabad
Keyskills: standard operating procedures development pharmaceutical medical management skills medicine nursing cardiovascular oncology quality healthcare assurance quality management operations compliance design regulatory affairs icu operational excellence communication skills
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