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Senior Executive / Assistant Manager - Ivd

5-8 years
Not Disclosed
10 Feb. 10, 2025
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

Position: Senior Executive / Assistant Manager - IVD
Experience Required: 5-8 years
Location: Hyderabad
Employment Type: Full-Time

Company Overview:

Promea Therapeutics is an innovative medical device manufacturing company specializing in Life Science products and Diagnostics, including Clinical Chemistry, Immunodiagnostics, Molecular Diagnostics, and Infusion Therapies. Our mission is to impact global healthcare markets by providing greater access to quality diagnostics and critical care parenteral products.

With a skilled and dedicated R&D team, we are driven by precision, quality, and innovation. Our state-of-the-art manufacturing facilities ensure high-quality production of In Vitro Diagnostic Medical Devices, Large & Small Volume Parentals, and Biologics to meet the needs of our customers.


Key Responsibilities:

  1. cGMP Implementation:

    • Ensure adherence to current Good Manufacturing Practices (cGMP) in the manufacturing plant.
  2. SOP Review:

    • Review and approve Standard Operating Procedures (SOPs) for compliance and accuracy.
  3. IPQA Activities:

    • Responsible for overseeing In-Process Quality Assurance (IPQA) activities at the facility.
  4. Line Clearance:

    • Ensure proper line clearance is performed before and after each production run.
  5. Sampling Activities:

    • Ensure sampling activities are conducted in accordance with established SOPs.
  6. Product Manufacturing:

    • Oversee the production of various diagnostic products, including RAPID, ELISA, Biochemistry, Hematology, Glucometers, and Electrolyte products.
  7. Review of Batch Records:

    • Review and approve Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
  8. Master Documents Review:

    • Review and approve Master Packing Card (MPC) and Master Formula Card (MFC).
  9. D&D & DEMF Review:

    • Review and approve Design & Development (D&D) documents and Design Evaluation and Master File (DEMF).
  10. Specifications, Stability, and COA Review:

  • Review and approve product specifications, stability data, and Certificates of Analysis (COAs).
  1. Process Validation Protocols:
  • Prepare and review Process Validation protocols to ensure compliance with industry standards.

Required Experience:

  • Medical Device Industry Experience:
    Proven experience in the medical device manufacturing industry, particularly in the field of In Vitro Diagnostics (IVD).