Quality Control Associate - Molecular Biology

Dr. Reddys Laboratories Limited; Hyderabad; Vor Ort; INR 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

Dr. Reddys Laboratories Limited is seeking a seasoned Quality Control professional to drive batch release testing and stability programs in a fast-paced manufacturing environment.

You will plan and execute SDS-PAGE, Western Blot, ELISA, CE-SDS and related QC assays, maintain compliance with cGMP and SHE, and report deviations with robust investigations. Candidates should hold a Masters in Biotechnology, Microbiology or Biochemistry with 6–9 years of QC experience, strong analytical and

Qualifikationen

• Masters degree in Biotechnology, Microbiology, or Biochemistry.
• 6–9 years of experience in quality control or related field.
• Strong attention to detail and analytical skills.

Aufgaben

• Plan and execute QC assays for batch release and stability.
• Maintain compliance with cGMP and SHE standards.
• Report deviations and investigations with proper documentation.
• Calibrate and maintain QC equipment and update procedures.
• Collaborate with cross-functional teams to improve QC processes.

Kenntnisse

Quality control

Statistical analysis

Documentation

Communication

Ausbildung

Master's degree in Biotechnology/Microbiology/Biochemistry

Tools

QC software

Jobbeschreibung

Responsibilities

• To Plan and execute SDS-PAGE, Western Blot, Dot Blot, IEF, assays for batch release and stability with in defined TAT.
• To Plan and execute HCD, Mycoplasma(RT-PCR) assays for batch release and stability with in defined TAT.
• To Plan and execute ELISA techniques like HCP and Pro A ELISA assays for batch release and stability with in defined TAT.
• To Plan and execute CE-SDS and CZE assays for batch release and stability with in defined TAT.
• To plan and execute Physicochemical, Biochemical assays for batch release and stability with in defined TAT
• To comply and maintain the laboratory with cGMP practices.
• To adhere and follow the safety practices and procedure as per SHE.
• To report Laboratory failures, Deviations, OOS, OOT upon observation and address the same through proper investigation.
• Maintain accurate and up-to-date quality control documentation and records
• Collaborate with cross-functional teams to implement and improve quality control processes
• Monitor and ensure compliance with industry standards, regulations, and company policies
• Participate in continuous improvement initiatives to enhance product quality and efficiency
• Calibrate and maintain quality control equipment to ensure accuracy in testing
• Assist in developing and updating quality control procedures and protocols
• Train and guide team members on quality control best practices and procedures

Qualification & Experience

• Masters degree in Biotechnology/Microbiology/Biochemistry, or a related field
• 6-9 years of experience in quality control or a related field
• Strong knowledge of quality control methodologies and statistical analysis
• Proficiency in quality control software and data management tools
• Familiarity with industry standards and regulations relevant to manufacturing
• Excellent attention to detail and analytical skills
• Strong problem-solving abilities and critical thinking skills
• Effective communication skills, both verbal and written
• Experience with manufacturing processes and quality management systems
• ASQ certification or other relevant quality control certifications preferred
• Ability to work efficiently in a fast-paced environment
• Strong organizational skills and ability to manage multiple priorities