Senior Executive

4-6 years

Not Disclosed

India

10 Aug. 22, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Summary:

Role: Senior Executive
Department: Quality Assurance
Location: Unit 2
Educational Qualification: M.Pharm, M.Sc
Experience Required: 4-6 years

Job Description:

Conduct GAP assessments to compare SOPs with actual practices.
Identify and rectify gaps in the QMS system according to EU annexure requirements.
Manage QMS documents, including Change Control, Deviations, OOS, CAPA, incidents, APQR, and investigations, and ensure timely closure.
Track and trend QMS documents.
Review online documents.
Oversee online monitoring activities, including dispensing of RM/PM, line clearance, IPQA activities, and verification of status labels.
Perform In-process Quality Assurance checks for Quality Control and production, and ensure corrective actions are followed up.
Review in-process and finished product TDS and COA.
Ensure compliance on the shop floor.
Handle qualification activities such as IQ, OQ, and PQ in coordination with user departments and engineering.
Assist in validation activities at the manufacturing site.
Prepare and review APQRs.

Skills Required:

GAP assessment for SOP vs. practices
Identification and rectification of gaps in the QMS system according to EU annexure
Management of QMS documents including Change Control, Deviations, OOS, CAPA, incidents, and APQR
Trending and tracking of QMS documents
Online document review

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Senior Executive

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