About the Company:
The Organization has taken a few significant steps in the basic area of Innovative work (Research and development). It has extended its Research and development office in Goa to lead research in Original Medication Conveyance Frameworks (NDDS) and artificially combine non-encroaching courses for the assembling of clinical items coordinated at managed markets. In its work to drive development, Unichem has laid out a restrictive plan improvement focus in Goa to zero in on the improvement of nonexclusive definitions containing Prompt Delivery along with NDDS and ANDAs solely for the US market. The office has likewise been prepared to deal with the advancement of plans for New Synthetic Elements (NCEs). Further, the organization has likewise settled a Biotech office at Goa to create, plan, create and market Biotech and Biosimilar items.
Established by Late Mr. Amrut Mody, Unichem Labs Ltd. is one of India's most regarded drug organizations resolved to convey better wellbeing through unrivaled items.
Unichem has a few pharma items that address the necessities of significant and developing restorative regions like gastroenterology, cardiology, diabetology, psychiatry, nervous system science, hostile to bacterials, hostile to infectives and torment the executives.
About the Job:
Experience: 8-10 years
Qualification: MSc or M. Pharma
Roles and Responsibility:
Audit change controls, deviations, and other quality framework examinations given by different areas and send them to corporate for survey and endorsement.
Completely audit seller capability records including merchant surveys, TSE-BSE articulations, basic and nitrosamine statements, and quality arrangements, and interface with the connected offices to guarantee documentation is finished according to the cGMP necessities.
Execute inward reviews at all Unichem fabricating areas and corporate offices according to the yearly organizer.
Freely execute merchant reviews - Programming interface, KSM, excipient offices, and outsider adjustment labs and guarantee definite reports are ready and CAPA is acquired from the sellers.
Plan and issue CQA rules to all locales and keep up with all CQA documentation in accordance with great documentation rehearses.
Audit SOPs of corporate divisions and give proposals to progress.
Audit process approvals convention and reports, security conventions, MPRs of Corporate divisions, and hardware capability records and give proposals to enhancements.
Basic skills
Active involvement with working inward reviews and in logical information survey.
Active involvement with review trail audit of all QC gear and information reinforcement/reclamation.
Working information on scientific strategy approvals/insightful technique moves.
8-10 years in QA or CQA - Programming interface office USFDA/EU GMP reviewed offices and having careful information and experience of QMS and gear capabilities.
Information on SAP/LIMS is ideal
Great correspondence, relational abilities, and eye for detail.
Capacity to work in a speedy, nimble, requesting and course of events driven climate