About Hetero :
The company established in 1993, and is of Indian origin, recently completed 25 years of expertise. This is equipped with 36 state of art facilities for manufacturing distributed globally and approved by many regulatory authorities like USFDA, TGA,MHRA, MCC and so on. Company has a profile, as on of the largest producer of anti retroviral drugs for the treatment of HIV/AIDS. Research and development department is given as strong pillar.
Coming to the portfolio there are about 300 plus products including HIV/AIDS, oncology, immunology, nephrology, cardio vascular, diabetics, urology and so on, these produce a revenue of over 2 billion $ by supplying to around 126 countries worldwide. The firm has centers distributed in Europe, USA and in Argentina there by continuously striving for the progress of the mankind and aiding in providing affordable medicines.
When comes to the API (Active pharmaceutical ingredient), this is one of the largest producer in the world, have large scale production capability with a portfolio of more than 300 API. Visakhapatnam located in andhrapradesh,API plant is one of the Asia’s largest SEZ complex, having around 500 acers of excellence area.
This has made a step in oncology portfolio (having 35 plus drugs) and providing medicines at economical prices. Furen Hetero, recently started in china, which is a joint venture between hetero and Furen group in oncology group.
Research and development started division started in 1995, giving opportunity to more than 1000+ scientists, ultimately providing the niche generics, NDDS (Novel drug delivery system), Complex API. Hetero research foundation is a state of art facility with diverse specializations. The group also having biological facility along with its manufacturing and API operations.
About the Job :
Experience : 9-14 years
Location : Choutuppal, Nakkapalle, Visakhapatnam, Tuni, Hyderabad/Secunderabad, Vizianagaram
Requirement :
Should have the Exposure to different QC instrument related software like Empower / Lab solutions / Tiamo / spectrum / Master sizer etc. is essential.
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.
Must have good exposure in calibration of all major QC instruments
To provide training to team members.
need to have the Hands on experience on all major QC instruments and software
Review of electronic data, audit trails in all QC / Microbiology applications.
Ability to review hard copy / soft copy raw data in QC instruments and identifying the gaps with remediation
Review of QMS documents like laboratory incidents / deviations/ change control / OOS /OOT, Abnormal trends /calibration failures / communication failures and further impact assessments.
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.