QC associate
QC associate
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Job Description
We are seeking an associate for the Quality control -Analytical team responsible for conducting analysis of Biosimilar products ( drug substance drug products and their in-process samples and stability samples). The role involves ensuring accuracy in documentation adherence to safety procedures reporting discrepancies and maintaining lab safety.
Roles & Responsibilities
- To perform analysis in Quality control analytical laboratory for the Biosimilar /Biologics Products as per the planning allotted by Team lead
- To perform chromatography techniques like RP-HPLC Glycan SEC IEX pep map for Biosimilar Molecules
- Having 2 to 6 years of experience
- Method Validations on RP-HPLC Glycan SEC IEX pep map
- To Perform Biochemical Physico chemical and chromatographic analysis
- Adhering to GMP practices
- Adhering to Good documentation practices
- Adhering to Good Analytical Practices
- Adhering to Regulatory Requirements including Internal or External audits Audit readiness and Query response drafting.
- Adhering to compliance of systems in Quality Control by working with relevant stake holders
- To adhere and follow the safety practices and procedures.
- To adhere to various cGMP procedures and internal SOPs
Qualifications :
Educational qualification:
A Masters degree in Biotechnology/ BE Biotechnology/B Tech Biotechnology or in Biochemistry domain.
Minimum work experience:
2 to 6 years of experience in QC analytical testing in Biosimilar products
Skills & attributes: Technical Skills
- Proficient in handling SEC/RP/IEX/Peptide Mapping/Glycan analysis of Biosimilar Products
- Proficient in handling of Gel electrophoresis/CE/HCP/HCD analysis of Biosimilar products
- Knowledgeable about cGMP SOPs and STPs ensuring accurate documentation and adherence to specifications.
- Adheres to safety precautions and procedures during analysis emphasizing the importance of lab safety JSA (Job Safety Analysis) and proper use of PPE (Personal Protective Equipment).
- Expertise in handling and upkeep of the chemical and solvent store including the preparation and maintenance of volumetric solutions and reagents.
- Method Validations on HCP/HCD/CZE/SDS PAGE
Behavioural Skills
- Keen attention to detail in analysis and documentation ensuring accuracy in all tasks.
- Effective communication and collaboration skills for communicating with the Group Leader reporting discrepancies incidents and providing timely updates.
- Takes initiative in ensuring the proper use and care of instruments timely destruction of samples and other assigned responsibilities.
- Demonstrates problem-solving skills in addressing discrepancies incidents and ensuring smooth laboratory operations.
- Upholds ethical standards compliance with SOPs and follows regulatory requirements in all activities.
Additional Information :
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions...
For more details please visit our career website at Work :
No
Employment Type :
Full-time
Employment Type
Full-time
