Quality Control Associate - Bioassay Testing

Dr Reddys Laboratories; Hyderabad; Vor Ort; INR 600.000 - 900.000; Vollzeit

Benefits dieser Stelle

joining & relocation support

family support (Maternity & Paternity)

learning and development opportunities

medical coverage for yourself and your

life coverage for yourself

Zusammenfassung

Dr. Reddy's Laboratories Ltd. is seeking a Quality Control Associate - Bioassay to test samples and release results within Turnaround Time for commercial and stability batches.

Calibration and maintenance of assigned equipment will be performed according to departmental procedures, ensuring accuracy within timelines. The role requires an MSc/MTech/BTech in Microbiology, Biochemistry or Biotechnology with 2–5 years of hands-on experience in bioassays, analytical techniques, and working in a cGMP

Qualifikationen

• Educational qualification as stated: MSc/MTech/BTech in Microbiology, Biochemistry or Biotechnology.
• Hands-on experience with bioassay techniques and analytical methods is required.
• Experience in a cGMP environment and GDP practices is preferred.

Aufgaben

• Bioassay testing for assigned samples and data release within defined timelines.
• Prepare reagents and buffers; ensure instrument availability for analysis.
• Document activities with GDP-compliant records and perform post-analysis checks.
• Inform supervisor of risks; provide data and analysis to support investigations.
• Adhere to QMS and timelines; participate in lab investigations and audits.
• Maintain lab cleanliness, proper sample storage, labeling, and calibration.
• Address instrument issues and perform root cause analyses; train new teammates on techniques.

Kenntnisse

Cell-based bioassays

SPR technique

FACS techniques

Bioassay analytics

Electrophoresis

ELISA

Protein chemistry

cGMP compliance

GDP awareness

Tech transfer

Strong communication

Ausbildung

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

Jobbeschreibung

Quality Control Associate - Bioassay

Company Description: Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait. We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity - to strengthen our core further (the next steps) and to build the future (the new bets). 'The Next and the New' is how we aim to continue to be the partner of choice - purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose - helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency. Dr Reddy's maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Description

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

• Bioassay testing for assigned samples and releasing data within defined timelines, ensuring absence of executional errors against established procedures.
• Preparing required reagents and buffers in alignment with the testing plan and ensuring the availability of equipment for analysis.
• Documenting activities contemporaneously, adhering to Good Documentation Practices and compliance expectations, and conducting self-checks post-analysis to ensure accuracy.
• Informing the supervisor about risk actions, providing necessary data and analysis to support the investigation process.
• Adhering to QMS (Quality Management systems) and closure timelines, actively participating in laboratory investigations and discrepancy closures, fulfilling defined roles in audits.
• Ensuring lab cleanliness, proper sample storage, chemical labeling, removal of expired material, usage of calibrated equipment, equipment calibration, maintenance, and qualification.
• Addressing instrument-related issues and conducting root cause analyses (RCAs) for unknown problems, and playing a crucial role in training new team members on analytical techniques.

Qualifications

• Educational Qualification: An M.Sc., M.Tech. or B.Tech. in Microbiology, Biochemistry, or Biotechnology
• Minimum Work Experience: 2-5 Yrs.
• 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 Bioassay, 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, tech transfer.
• 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 At Dr. Reddy's

• 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. 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. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're 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 https://careers.drreddys.com/#!/

Experience Level Mid Level