Analytical Quality Assurance Associate Biosimilars

Job summary
We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations ensuring smooth batch manufacturing and testing activities and evaluating practices against defined standards to ensure consistent product quality and operational compliance within the regulatory framework and global standards.

Roles & Responsibilities

• Involve in Analytical data review and Approval.
• Review of batch analytical record for batches manufactured at CMO.
• Review and Approvals of analytical Method Transfer Validation Protocol and Reports.
• Preparation Review and Approvals of Study protocols and Reports.
• Review and Approvals of stability Protocols Reports and related documentation generated from the stability studies of the products.
• Preparation Review and Approvals of procedural documents such as SOPs / STPs / Specifications and ROAs pertaining to Quality control in accordance with current QA requirements.
• Analyst Qualification review and Authorization
• Instrument Calibration review and Authorization
• Assuring compliance on the QC floor through Lab round.
• Participate in QC Analytics LDM and update on Quality slides.
• Support for audit related activities as per requirement
• QC instrument Audit Trail support.
• You will be tasked with checking the adherence to the Quality Management System (QMS) elements such as change control incident management and CAPA (Corrective and Preventive Actions) management on the shop floor.
• You will provide essential support to the supervisor in conducting investigations related to complaints batch failures Out-of-Specification/Out-of-Trend (OOS/OOT ) results incidents etc. by collating data and conducting interviews.
• You will coordinate with cross-functional teams to facilitate and drive the investigation process conduct a thorough root cause analysis document CAPA verify implementation within the agreed timeline and monitor its effectiveness over time.
• You will be responsible for supporting or assigning personnel to assist in internal and external audit activities following the instructions of superiors providing necessary information documents and clarifications to supervisors during actual audits and maintaining appropriate records.
• You will follow up with respective user departments to share audit responses and diligently track and maintain the closure of action items arising from audits as needed.

Qualifications :

Educational qualification: A . or Post-Graduation (Life Sciences)

Minimum work experience: 4 years of industrial experience with specific operational experience in Manufacturing Quality Control Quality Assurance or Engineering & Development

Skills & attributes:

Technical Skills
A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization.
In-depth knowledge and comprehension of the Bio Pharma and Pharma markets including product knowledge market trends competitors and customer needs.
Understanding and familiarity with global cGMP (Current GMP) regulatory requirements including those set by FDA (U.S. Food and Drug Administration) EU (European Union) and Indian regulatory authorities.
Awareness of broader market dynamics industry trends and factors influencing the pharmaceutical market.
Comprehensive knowledge of the specific products associated with the pharmaceutical organization including their characteristics manufacturing processes and quality requirements.
Ability to understand and implement organizational policies and ensuring compliance.

Behavioural skills
Demonstrates a commitment to continuous learning.
Strong communicating and influencing skills.
Displays analytical and logical thinking abilities.
Is self-motivated and takes initiative.
Adaptability to the work environment along with being a team player.
Ability to go beyond boundaries showcasing a proactive and innovative 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.
With a robust portfolio of biosimilar products across key therapeutic areas covering US$80 Bn in innovator sales future business pipeline covers a variety of product classes and therapy areas and new modalities. Fully integrated organization with over two decades of experience in developing manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities in-house clone development upstream and downstream process development bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900000 patients having benefited from our products till date.

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 Work :

No

Employment Type :

Full-time

Experience: years
Vacancy: 1