Dr Reddy is hiring for the role of Quality Control Associate – Bioassay in Hyderabad, India. This opportunity is suitable for candidates with experience in bioassay testing, GMP documentation, cell culture, and biochemical analysis techniques within a Quality Control environment.
Job Details
| Company | Dr Reddy |
| Position | Quality Control Associate – Bioassay |
| Department | Quality Control |
| Location | Hyderabad, India |
| Experience | 2 years- 7 years |
Job Description
The selected candidate will be responsible for testing samples and releasing results within Turnaround Time (TAT) for commercial and stability batches, while following GMP (Good Manufacturing Practices). The role includes calibrating and maintaining assigned equipment as per departmental and organizational guidelines, processes, and procedures. The key objective is to ensure accurate results are delivered within defined timelines.
Key Responsibilities
- Perform Bioassay testing for assigned samples and release data within defined timelines.
- Ensure absence of executional errors against established procedures.
- Prepare required reagents and buffers in alignment with the testing plan.
- Ensure availability of equipment for analysis.
- Document activities contemporaneously while following Good Documentation Practices and compliance expectations.
- Conduct self-checks after analysis to ensure accuracy.
- Promptly inform the supervisor about risk actions and provide required data and analysis to support investigations.
- Adhere to QMS (Quality Management systems) and closure timelines.
- Actively participate in laboratory investigations and discrepancy closures, and fulfil defined roles in audits.
- Maintain lab cleanliness, proper sample storage, chemical labeling, and removal of expired material.
- Ensure use of calibrated equipment and support equipment calibration, maintenance, and qualification.
- Address instrument-related issues and conduct root cause analyses (RCAs) for unknown problems.
- Train new team members on analytical techniques.
Qualification
- An M.Sc.,M.Tech. or B.Tech. in Microbiology, Biochemistry, or Biotechnology
Experience
- 2 years- 7 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.
Benefits Offered
- Personalised learning programs to support career growth and professional development.
- Joining & relocation support.
- Family support including Maternity & Paternity benefits.
- Learning and development opportunities.
- Medical coverage for yourself and your family.
- Life coverage for yourself.
How to Apply
Interested candidates can apply online through the official Dr Reddy careers link below.
