1. Responsible to manage Analytical Services laboratory activities in compliance with respect to GMP, GLP and Safety.
2. Preparation, review of Standard Operating Procedures as per the requirement.
3. Ensure the Lab Complaince of Analytical Services in co-ordination with Quality Assurance.
4. Ensure to comply with ISO-9001:2015 QMS, CGMP and actively involve in internal and external audits.
5. To provide support in the Audits.
6. To provide support in the investigation and conclusions of Laboratory Incidents/ Deviations/Change controls etc.,
7. Develop Train the laboratory staff to meet the Lab Compliance.
8. Co-ordinating with the service engineers for the break downs/preventive maintainence or any qualifications etc.,
9. Co-ordinating with Service engineer at the time of IQ, OQ, PQ and maintenance of the instruments.
10. Review of instrument IQ, OQ, PQ data and ensure the Back up of the sysytems.
11. Coordinating with external agencies for timely out sourced calibrations and services.
12. To ensure that the preventive maintenance and calibration of the instruments are performed as per the defined schedule.
13. To Raise the purchase requisitions for the Instruments and other requirements.
14. To co-ordinate with external agencies for timely out sourced calibrations and services.
15. Updation of day to day activity to the HOD.
Salary: INR 3,00,000 - 6,00,000 P.A.
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: R&D
Role: Bio/Pharma Informatics-Associate/Scientist
Employment Type: Permanent Job, Full Time