Quality Control Associate - Bioassay ( Supervisor )

Job Summary

We are seeking an individual to test samples and release results within Turnaround Time (TAT) for commercial and stability batches, adhering to GMP (Good Manufacturing Practices). This role involves calibrating and maintaining assigned equipment within departmental and organizational guidelines, processes, and procedures. The primary objective is to ensure accuracy in results provided within timelines.

" Roles & Responsibilities

Your responsibilities encompass Bioassay testing for assigned samples and releasing data within defined timelines, ensuring absence of executional errors against established procedures. You will be responsible for preparing required reagents and buffers in alignment with the testing plan and ensuring the availability of equipment for analysis.

Your role involves documenting activities contemporaneously, adhering to Good Documentation Practices and compliance expectations, and conducting self-checks post-analysis to ensure accuracy.

You will promptly inform the supervisor about risk actions, providing necessary data and analysis to support the investigation process. You will adhere to QMS (Quality Management systems) and closure timelines, actively participate in laboratory investigations and discrepancy closures, fulfilling defined roles in audits.

Your responsibilities also include ensuring lab cleanliness, proper sample storage, chemical labeling, removal of expired material, usage of calibrated equipment, equipment calibration, maintenance, and qualification.

You will address instrument-related issues and conduct root cause analyses (RCAs) for unknown problems, and play a crucial role in training new team members on analytical techniques.

Educational Qualification

An M.Sc., M.Tech. or B.Tech. in Microbiology, Biochemistry, or Biotechnology

Minimum Work Experience

6 - 10 years

Skills & Attributes Technical Skills:

Basic understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends.

Hands-on experience in cell based bioassays, SPR technique, FACS techniques.

Basic knowledge and hands-on exposure to cell culture techniques, specifically for working in Bioassay (BA) Labs.

Hands-on experience in Biochemical analysis techniques, specifically Electrophoresis, Enzyme-Linked Immunosorbent Assay (ELISA), and Polymerase Chain Reaction (PCR), with a focus on Analytics.

Working experience in a cGMP (Current Good Manufacturing Practice) environment, with a special emphasis on Good Documentation Practices (GDP).

Basic knowledge in protein chemistry, including an understanding of protein structure, function, and relevant analytical techniques.

Basic understanding about bioassay method validations.

Behavioural Skills:

Prioritizes effective communication and demonstrates a performance-oriented mind-set.

Effective verbal and written communication skills.

Performance-oriented approach, consistently striving for high standards.

Demonstrates flexibility in working shifts and a clear understanding of team dynamics.

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon...

" Benefits Offered

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

" Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions...

For more details, please visit our career website at  https://careers.drreddys.com/#!/