Hetero Plasma Science-Interview For Process R&D/ AR&D/ QC Micro/ QC/ IPQA/ AQA/ Vendor Management 24th February, 2024

Hetero Plasma Science-Interview For Process R&D/ AR&D/ QC Micro/ QC/ IPQA/ AQA/ Vendor Management 24th February, 2024

Hetero Plasma Science-Interview

Hetero Plasma Science Pvt. Ltd (a Hetero Group) is one of Indias generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. HETERO is one of the India’s leading generic pharmaceutical companies and is one of the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar.

Process R&D
Exp : 4-6y
Experience in Process development/ downstream processing/ Scale-up/ Technology transfer for plasma or biological products.

Analytical R&D
Exp : 4-7y
Experience in Analytical method development and validations for testing of plasma products or other biological products

QC – Microbiology
Exp : 2-4y
1. Good hands-on experience in BET testing of biological products
2. Proficient in good microbiological practices
3. OOS, OOT, deviation handling and CAPA management

QC Product testing Instrumentation
Exp : 2-4y
Biochemical & Instrumentation based Testing :
1. Handle instruments & test methods based on Spectrophotometer, 96 well plate readers, microscope, HPLC, GC, Kjeldahl equipment etc. Reagent, reference standards, materials, samples management & documentation, 3.Analytical test report execution, instrument logs, report OOT,
OOS, incident & deviations, Prepare, implement SOPs, STPs, Specifications and protocols. Update them as per the current regulations. Proficient in GLP & GDP practices

IPQA
Exp : 4-9y
1. Perform and Monitor In-process Quality Assurance and line clearance activities during the different stages of DS & DP manufacturing process, Warehouse and Plasma testing areas.
2. Responsible for Monitoring of cleanroom behaviour, aseptic activities and in-Process sample management and media fills.
3. Preparation and Review of production batch documents i.e., BMR, BPR, SOPs, Protocols and other GMP documents.

QC Product testing
Exp : 8-11 years
Bio Chemical Testing
1. Should be able to handle a team of about 5-6 members,
2. To handle Biochemical & Immunochemical based test methods in QC Biological product testing,
3. Plan, perform and ensure completion of equipment qualifications, method validations & analyst qualifications.
4. Must have good hold on pharmacopoeia monographs & regulatory guidelines pertaining to Biopharma quality testing.
5. Prepare, implement SOPs, STPs, Specifications and protocols. Update them as per the current regulations. Proficient in GLP practices.
6. Proficient in review of analytical test reports, audit trails & instrument logs, Handle incidents, deviations, OOT & OOS results to department head and ensure implementation of CAPA.,Good in GXP practices

QA Analytical
Exp : 4-9
1. Review and monitoring of analytical testing activities conducted by laboratory personnel, review of test results, data sheets and analytical reports to ensure compliance with testing protocols and regulatory requirements, analytical methods, specifications, STPs, Method of analysis. GTPs and protocols to ensure compliance with regulatory standards and industry best practices.
2. Responsible to review BET. MLT, Bioburden, Sterility, Environmental monitoring and Personnel monitoring procedures and activities related to Microbiology.
3. Review and evaluate customer complaints, stability data, Out of Specification (OOS) investigations and Out of Trend (OOT) results.

Vendor management
Exp : 2-4 years
1. Identify potential vendors, suppliers and service providers in coordination with R&D/Purchase departments. Evaluate vendor capabilities, qualifications and performance against predefined criteria to select suitable partners.
2. Responsible to address issues, disputes, and conflicts that arise during the course of vendor engagements. Collaborate with internal stakeholders and vendors to identify root causes, implement corrective actions, and escalate unresolved issues as necessary to achieve timely resolution.
3. Prepare and review audit agendas, audit observation reports, and quality agreements. Ensure vendors compliance with audit requirements and conduct reviews of their compliance reports.

Qualification : M.Sc Biotechnology, Biochemistry, Microbiology, M.Pharm / B.Pharm
Preferable Biologics/lnjectables

Walk in Interview
Date : 24th February, 2024 (Saturday)
Time : 9am – 2pm
Venue : Hetero Corporate Office Sanathnagar, Hyderabad

Job Category: pharma
Job Type: Full Time
Job Location: Sanathnagar

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