Ultratech India Limited is an ISO certified Pharmaceuticals and Bulk drugs manufacturing firm based in Navi Mumbai. Our manufacturing plant is located in Taloja MIDC and office is at Vashi, New Mumbai.
Post : Sr. Executive Quality Assurance
Job Description
- Should have faced USFDA / MCA / PICS audits.
- Should be proficient with plant / environment / documents requirements of international authorities like USFDA / UK MHRA / MCA / TGA / PICS / WHO-Geneva.
- Involvement in quality assurance work of project from green field stage shall be most suitable.
- Should be conversant with current GMP / GLP international guidelines.
- Should have information to prepare documents such as facility URS / Design qualification (DQ) / Installation Qualification (IQ) / Performance Qualification (PQ).
- Should have enough understanding to prepare / to execute SOP’s (Standard operating procedures) for different departments such as Stores / R&D / Quality Control / Production / Utility & Maintenance.
- Should be capable to prepare / to execute / to ensure & maintain quality documents / forms / formats for smooth working of plant.
- Should have conceptual knowledge about Air handling units / clean room partitioning / ACPH requirements / differential pressure zones as per current pharma requirements.
- Should have substantial knowledge of DMF / Dossier preparation.
- Should have sufficient knowledge to prepare / to execute / to maintain documents related to Change Control / Complaints Handling / Product Recall / Job training / Corrective & Preventive maintenance of plant and machinery / Corrective Action Preventive Action (CAPA) etc.
- Should have exposure to QC (Chemical test & Instrumentation) / R&D /Production (Chemical Synthesis / Formulation development) / Maintenance activities in API / Pharmaceutical Formulation Plants.
Candidate Profile :
B.Sc. (Chemistry)/ M.Sc.(Organic/Analytical Chemistry) / B.Pharm. / M.Pharm, Total experience of 2 to 5 years in core quality assurance work / Faced plant audits from International authorities like USFDA / UK MHRA / MCA / TGA / PICS / WHO-Geneva.
Additional Information:
Experience: 2-5 Years
Education: B.Pharm, B.Sc, M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA
End Date: 14th January, 2017
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