Shilpa Bio Hiring candidate for QC Analytical Department

Department : QC Analytical
Experience : In Biotech QC 12-15 years
Qualification: Post-Graduation in Biotech / Analytical
Designation: QC Head – Senior Manager

Job Description:
1.     Responsible for overall Quality Control Analytical Department operations for Biotech product testing (release and stability) and Bio-Analytical Lab Clinical samples.
2. Responsible to ensure on-time analytical support to production/manufacturing.
3. Responsible to maintain the analytical lab as per established procedure and regulatory guidance.
4.     Responsible to ensure the on-time testing of samples for analytical tests.
5. Review and approve Certificate of Analysis, Certificate of Test, and stability studies.
6 Responsible to maintenance of analytical department clean rooms as per established procedures.
7.     Responsible for review and approval of Standard Operating Procedures (SOPs).
8.     Responsible for review and approval of equipment, area qualification documents and execution for analytical laboratory instruments.
9.     Responsible for review, tracking and timely closure of QMS events.
10.   Responsible to ensure all equipment/instrument in qualified/calibrated state.
11.   Responsible for preparation, review and approval of Techno-commercial data for analytical and quality control laboratory equipment’s & instruments.
12.   Responsible to ensure and provide required training and guidance and support to all analysts for execution analytical tests (as required). 
13.   Responsible to provide functional support to cross functional teams and to participate in the quality review meetings.
14.   Responsible for quality interface in audits, ensure appropriate compliance response with action plan are provided and appropriate CAPA identified are closed out timely.
15. Responsible to follow and ensure the Safety and wearing of appropriate PPE’s in analytical lab.
16.   Responsible to ensure the GDP and Aseptic Practices being followed in analytical lab.
17.    Responsible to ensure Data Integrity in analytical department.
18.    Responsible for recruitment and managing the available manpower.
19. Responsible for preparation and review of Revenue and Capex budget for analytical function.

Interested candidates can share your CV’s to hrd_bio@shilpabio.com