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.
- Vacancy details:
- Department: Team Member-Injectable Development Quality Assurance
- Qualification: M.Sc
- Experienced: 2- 5 Year
- Salary: ₹Not Disclosed
Job Description: Greetings from Msn laboratories pvt ltd..!!
Important Details :
- Location: Hyderabad
- Post of date:18/10/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face To Face Interview
- Interview Rounds of Interview: HR
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 product development teams.
• 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 advantageous
Minimum work experience: 5-7 years of experience in the pharmaceutical industry, with a focus on product development and quality management
Skills & 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.
