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Senior Executive / Assistant Manager - Ivd

5-8 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Title: Quality Assurance Executive - Medical Devices

Company Overview:
Promea Therapeutics is a leading medical device manufacturing company, specializing in Life Science products and Diagnostics, including Clinical Chemistry, Immunodiagnostics, Molecular Diagnostics, and Infusion Therapies. We are committed to making a meaningful impact on global healthcare by enhancing access to high-quality diagnostics and critical care parenteral products. Our highly skilled R&D team strives for precision, quality, and innovation, supported by state-of-the-art manufacturing facilities that ensure the production of In Vitro Diagnostic Medical Devices, Large & Small Volume Parentals, and Biologics.

Key Responsibilities:

  • Implement and enforce cGMP practices across the plant.
  • Review and update Standard Operating Procedures (SOPs).
  • Manage IPQA activities within the facility.
  • Oversee and provide line clearance as per requirements.
  • Ensure that sampling activities are conducted according to SOPs.
  • Oversee the production of RAPID, ELISA, Biochemistry, Hematology, Glucometers, and Electrolyte products.
  • Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
  • Review and approve Master Packing Cards and Master Formula Cards.
  • Review D&D (Design & Development) and DEMF (Design and Engineering Master Files).
  • Approve and review Specifications, Stability, and Certificates of Analysis (COA).
  • Prepare and review Process Validation protocols.

Required Experience:

  • Previous experience in medical device manufacturing is essential.