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Officer

2 to 6 years
Not Disclosed
10 Nov. 28, 2024
Job Description
Job Type: Full Time Education: B. Pharma / M. Pharma 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

This job description is for an Officer (E1) position in the PDL (FML) department at Lupin, located in Pithampur, Madhya Pradesh, India. The role focuses on process development and validation in the pharmaceutical manufacturing sector, particularly for Oral Solid Dosage Forms (OSDF). Candidates with 2 to 6 years of experience and a qualification in B.Pharma or M.Pharma are eligible.

Key Responsibilities:

  1. Manufacturing Knowledge:

    • Expertise in the manufacturing processes of Oral Solid Dosage Forms (OSDF), including:
      • OC/HPD formulations (Occupational and Highly Potent Drugs).
      • Immediate Release (IR) dosage forms.
      • Techniques such as Dry Granulation and Wurster/Top Spray Granulation processes.
  2. Shop Floor Activities:

    • Manage and oversee shop floor activities during shifts to ensure smooth and compliant operations.
  3. Process Development & Validation:

    • Proficiency in Process Development, Process Design, and Process Validation, aligning with regulatory standards.
  4. Regulatory Awareness:

    • Familiarity with regulatory guidance and requirements for US/EU and other regulated markets.
  5. Execution of Batches:

    • Lead and execute development, scale-up, exhibit, and validation batches, ensuring adherence to protocols and quality standards.
  6. Document Review:

    • Review key documents such as Scale-Up/Exhibit/Validation protocols, Reports, and Batch Manufacturing Records (BMRs) for accuracy and compliance.
  7. Documentation and Communication:

    • Demonstrate strong communication and writing skills, with a commitment to Good Documentation Practices (GDP).
  8. Software Proficiency:

    • Experience with SAP and quality systems software to ensure streamlined operations and documentation.

Qualifications:

  • B.Pharma or M.Pharma

Relevant Experience:

  • 2 to 6 years in pharmaceutical manufacturing, with a focus on OSDF processes and regulatory compliance.

This position is ideal for professionals with a technical and regulatory understanding of pharmaceutical manufacturing processes, coupled with strong operational and documentation skills. It offers an opportunity to work in a dynamic and compliant manufacturing environment.