Development Quality Assurance Associate

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.

Qualifications :

Qualifications

Educational qualification: A Bachelors 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.

Additional Information :

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year time horizon...

Benefits Offered

At Dr. Reddys we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddys are on par with the best industry standards...

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...

For more details please visit our career website at  Work :

No

Employment Type :

Full-time