Hetero is a globally renowned vertically integrated pharmaceutical player engaged in research and development, manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas. Backed by 27+ years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Global Generics, Biosimilars and Custom Pharmaceutical Services. The company is among the largest producers of Active Pharmaceutical Ingredients (APIs) in the world.
- Role: Quality Manager / Supervisor
- Education: MS/M.Sc(Science) in Organic Chemistry, Bio-Chemistry, Biology, Microbiology, Chemistry
- Experience: 9 to 14 year(s)
- Locations: Choutuppal, Nakkapalle, Visakhapatnam, Tuni, Hyderabad/Secunderabad, Vizianagaram
echnical skills (Essential):
- Hands on experience on all major QC instruments and softwares
- Must have good exposure in calibration of all major QC instruments
- Ability to review hard copy / soft copy raw data in QC instruments and identifying the gaps with remediation
- Exposure to different QC instrument related softwares like Empower / Lab solutions / Tiamo / spectrum / Master sizer etc. is essential.
- To provide training to team members.
- Review of electronic data, audit trails in all QC / Microbiology applications.
- Review of QMS documents like laboratory incidents / deviations/ change control / OOS /OOT, Abnormal trends /calibration failures / communication failures and further impact assessments.
- Good communication and drafting skills for writing the investigation reports / trend reports / Comprehensive assessment of QMS elements and identifying root causes for repeated incidents / deviations / failures.
- Review of change controls and to assess the impact
- Good knowledge and experience in handling of QC instrument / applications related Qualifications, validations, Computerized system validations is essential.
Technical skills (Desired):
- Experience in ERP / LIMS / SAP / QMS applications etc.