Quality & Regulatory Specialist

is seeking a dynamic QA & RA Specialist to be based on site and reporting to QA & RA Manager.

Key Responsibilities:

Regulatory Affairs

• Support regulatory submissions for new registrations variations renewals transfers and line extensions
• Prepare and review regulatory documentation including Module 1 updates local annexes and product information (SPC PIL labelling)
• Manage artwork processes: review printed materials (PIL labelling cartons) ensure regulatory compliance and upload data into the artwork management tool
• Monitor regulatory changes (AIFA guidelines European Commission EMA updates)
• Support approvals of variations at local level including updating on AIFA portal where needed
• Maintain local regulatory databases and ensure documentation accuracy for inspections
• Support lifecycle management activities for marketed products

Quality Assurance

• Participate in drafting updating and implementing QA procedures (SOPs work instructions forms) in alignment with global and GDP/GMP requirements
• Support batch release activities including collecting and archiving batch documentation
• Support product quality complaints including collection of information/documentation for initial assessment
• Support supplier and service provider qualification including documentation collection and audit preparation
• Support Annual Product Quality Review (PQR) and Annual Quality Review (AQR) preparation and follow-up
• Support temperature excursion assessment
• Manage clearance (batch release) and market distribution documentation ensuring timely availability for commercial teams

Compliance and Documentation Management

• Maintain controlled documents (SOPs forms templates) within the Quality Management System (QMS)
• Ensure training compliance including tracking and supporting training activities for local teams

Affiliate Cross Functional Support

• Support tender documentation including providing regulatory certificates declarations or quality statements
• Collaborate with supply chain on product availability artwork changes and regulatory impact of stock management
• Facilitate the information flow among local warehouse provider and HQ
• Support to the implementation of the serialization project
• Participate in global/regional QA/RA initiatives and working groups

Qualifications :

Educational qualification: Degree in Scientific area (Biology / Biotechnologies / Biomedical Engineering)

Minimum work experience:

• 1-3 years of experience in pharma companies

Skills & attributes:

• Excellent Stakeholder management

• Solution focused ability to solve problems in timely manner

• Ability to adapt to dynamic environment

• Good cross functional collaboration and team work

Additional Information :

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. 

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.

Remote Work :

No

Employment Type :

Full-time