Production Specialist FFM

3.00 to 5.00 Years Hyderabad 19 May, 2020

Job Location	Hyderabad
Education	Not Mentioned
Salary	Not Disclosed
Industry	Pharma / Biotech
Functional Area	Production
EmploymentType	Full-time

Job Description

Candidate should have strong experience in Biosimilars / Sterile/ Injectable Mfg.
Handling of QMS activity like Deviation, Change control, OOS and CAPA.
To ensure that all production activities and documentation are carried out in compliance with the cGMP requirements.
Monitoring of GxP in manufacturing and escalation of risk associated with the practices on product quality.
Assessment of change controls for impact and review of mitigation plans for risk identified, ensure changes are implemented timely and closed.
Assessment of Deviations for Impact, Investigation mechanism and root cause analysis for logical and scientific aspects.
Ensure of manufacturing for area cleanliness , arrangement of items, equipment status labels, review of alarms of manufacturing equipment, escalation of gaps in the procedures and implementation CAPA.
Review of SOP s of manufacturing for controls in accordance with Regulatory guidelines and ensure procedures written are clear without ambiguity

Keyskills :
safetyquality documentationrequirements soproot cause analysis environmental impact assessmentcontinuous improvement facilitatio

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Production Specialist FFM

Job Description

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