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    Sr Executive / Asst Manager

    Promea
    3-8 years
    Not Disclosed
    Hyderabad
    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: Executive - Biologics Production

    Job Description:
    The Executive in the Biologics Production Department will play a crucial role in the manufacturing and production of biologic drugs at Promea. They will be responsible for ensuring efficient and compliant biologics production, adhering to quality standards, safety regulations, and production schedules.

    Key Responsibilities:

    • Plan and execute batches, ensuring adherence to schedules and quality standards.
    • Manage dispatch of drug substances and supervise documentation.
    • Oversee shift planning for manpower and material management.
    • Ensure facilities' cleanliness and manage the movement of personnel and materials across the facility.
    • Participate in validation studies in coordination with cross-functional departments.
    • Conduct risk assessments and root cause analysis for production challenges.
    • Train production personnel on all aspects of GMP (Good Manufacturing Practices).
    • Oversee IQ, OQ, PQ (Installation Qualification, Operational Qualification, Performance Qualification) for new equipment in collaboration with the Engineering and QA departments.
    • Manage change control processes in coordination with cross-functional teams.
    • Address breakdowns and resolve issues in coordination with utilities departments.
    • Plan and execute reprocessing activities for Albumin and IVIG (Intravenous Immunoglobulin), meeting set yields and quality standards.
    • Schedule and manage fumigation and CIP (Cleaning In Place) of vessels.
    • Plan and follow up on preventive maintenance schedules.
    • Ensure preventive care to maintain low levels of BET (Bacterial Endotoxin Test) in products and equipment.
    • Calibrate Chrom skid pH & Cond. meters as required.
    • Manage packing and unpacking of columns and troubleshoot as needed.
    • Troubleshoot critical equipment issues as they arise.
    • Gather resources and place orders for required materials.
    • Train junior staff on technical aspects of columns, TFF (Tangential Flow Filtration), centrifuges, and filtration processes.
    • Manage manpower and coordinate efforts to ensure smooth operations.
    • Coordinate with vendors during AMC (Annual Maintenance Contracts) of Chrom Skids, Columns, TFF, and SKADA equipment.

    Qualifications and Skills:

    • Bachelor’s degree in Pharmacy, Pharmaceutical Science, Life Science, or related field. B.Sc. (Chemistry as one of the subjects) is acceptable.
    • Minimum of 3-8 years of relevant experience in biologics production.
    • Ability to multitask, prioritize workload, and meet tight deadlines in a fast-paced environment.
    • Strong knowledge and experience in GMP, CGMP (Current Good Manufacturing Practices), GDP (Good Documentation Practices), documentation, and audits.
    • Ability to work effectively in a team environment, managing a large team and collaborating with senior leadership.
    • Excellent written and oral communication skills, with strong articulation abilities.

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