Virchow Biotech Pvt. Ltd is an ISO 13485:2015 and WHO – GMP certified leading global player in Bio – Pharma sector having more than 15 years of operational experience, situated at Hyderabad. We also have offices located in USA. Innovative, ever motivated Research team and uncompromising manufacturing team in providing quality products are our strength.
We have an immediate requirement for a Jr Research Associate or Research Associate (A R&D-Biologics) for VIRCHOW BIOTECH PVT LTD, Hyderabad, for the below-mentioned position.
Department: A R&D-Biologics
Designation: Jr Research Associate or Research Associate
No of Vacancies: 5
Qualification: M. Sc (Life Sciences), B. Tech or M. Tech (Biotech or Bio Chem)
Experience: 2 to 5 years
Budget: 2 to 5 Lpa
JOB DESCRIPTION:
Responsibilities:
1. Analytical method development and validation (MDR and MQR) for new drug molecules.
Operation and calibration of HPLC, pH meter, analytical balance, Franz diffusion cell apparatus etc.
Knowledge of good laboratory practices (GLP), good documentation practices and safety.
Preparation of standard testing procedures (STPs), standard operation procedures (SOPs) for equipment and instruments installed in R & D (Biologics).
5. SOP Preparation, SOP Revisions, Method development report , Qualification report ,Risk Assessment report and Qualification Plan.
6. Determination of protein concentration and protein content(Bradford method) & it’s separation (Moisture Content Method, ,SDS PAGE,IEF-Method)
7. Affinity Chromatography method (Protein-A)and RP-HPLC Method(Peptide Mapping Method, Single Chain Method, Quantative Method)
8. Hands on experience on UV Spectroscopy (Microplate Reader), UPLC with Empower3Software, IEX, SEC, Glycan Method and Troubleshooting of UPLC.
Interested candidates can share with the below mentioned mail-Id. [email protected]
We have an immediate requirement for a Sr Manager or AGM (Quality Control) for VIRCHOW BIOTECH PVT LTD, Hyderabad, for the below-mentioned position.
Department: Quality Control
Designation: Sr Manager or Asst General Manager
No of Vacancies: 5
Qualification: M. Sc, M. Pharma or Ph. D
Experience: 16 to 18 years
Budget: 18 to 20 Lpa
JOB DESCRIPTION:
Responsibilities:
1. Responsible for the overall activities of Quality control (QC) department in support of both biotech and pharma products.
2. Accountable for the preparation and approval of SOP’S for all QC test procedures, including method validation. Evaluates the current test procedures & methodologies and updates them as per the changing requirements & regulations.
3. Qualification and Handling of Working standards and its maintenance.
4. Preparation and execution of study protocols.
5. Responsible for timely release of quality control documents with accuracy
6. Handling of customer complaints & preparing Corrective Action Report.
7. Handling of joint analysis and preparation of joint analysis report
8. To check, investigate and review out of specification results data.
9. Initiation and handling of incidents and deviation.
10. To ensure & approval of the qualification documents for the new instruments received in the laboratory.
11. To monitor data integrity and laboratory compliance in the quality control department
12. Initiation and handling of change control as per requirement.
13. To ensure the safety compliance in quality control department.
14. Preparation of validated Excel sheets protocols, reports.
15. Execution validation of Excels sheets as per protocols.
16. To be responsible for Laboratory Quality management system and internal Audit.
17. To strategize and plan continual improvement in all laboratory activities as per GMP and GLP requirements.
18.To participate and documentation of the Internal and External audits and response to the audits to ensure compliance.
19.Coordinating with QA & RA departments for documentation to fulfill the audit requirements.
20. To train new personnel related to Quality control.
Interested candidates can share with the below mentioned mail-Id. [email protected]