Website DR.Reddys laboratories
Analytical QA experts from a biologics background are individuals who have experience and knowledge in the quality assurance and control of biologic products, such as vaccines and therapeutics made from living organisms or their derivatives. They may have a background in biology, biochemistry, or a related field, and may specialize in areas such as protein characterization, assay development, and stability testing. They are responsible for ensuring that biologic products meet the necessary quality standards before they are released for use in the clinic.
Responsibilites / Expectations as below :
- Understanding and hands-on experience with various analytical techniques such as HPLC, ELISA, TOC, and Glycan, as these are commonly used in the quality control and research and development of biologic products.
- Reviewing and approving analytical test methods and protocols to ensure they meet regulatory requirements and industry standards.
- Monitoring and auditing analytical testing performed by QC or R&D teams to ensure compliance with established procedures and protocols.
- Troubleshooting and resolving any analytical issues or deviations that may arise during testing.
- Participating in the review and approval of batch records and other documentation related to the production and release of biologic products.
- Keeping abreast of current regulatory guidelines and industry standards in order to ensure that the organization’s quality systems meet these requirements.
- Collaborating with other departments such as R&D, Production, and Regulatory Affairs to ensure that all analytical testing is performed in a timely and efficient manner.
- Participating in continuous improvement initiatives to enhance the effectiveness and efficiency of the analytical QA program.
Experience in facing FDA/EMEA/EU audit and Drafting Regulatory Queries response.
Review skills of BAR (Batch analytical record), Incidents, Change control, OOS and CAPA etc.
Skills in performing audit trail of QC instruments like HPLC, PCR, CE, plate reader etc.
Very good understanding of SAP and SAP handling
Experience in LIMS for analytical date review/Stability data review.
Good understanding of SOP, STP, specification etc…
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To apply for this job email your details to grandirpharma@gmail.com