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Officer - Quality Assurance

2-3 years
Not Disclosed
10 Dec. 19, 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

Officer - Quality Assurance
Company: Ahlcon Parenterals IN Ltd (B. Braun Group)
Location: Bhiwadi, Rajasthan, India
Functional Area: Quality
Working Model: Onsite
Requisition ID: 1030

Job Summary:
Ahlcon Parenterals (India) Limited, a B. Braun group company, is looking for a dedicated Officer for its Quality Assurance team. The selected candidate will be responsible for ensuring cGMP compliance across the site, managing dispensing of raw and packing materials, conducting in-process quality control checks, and supporting environmental and personnel monitoring procedures. The role involves ensuring compliance with regulatory guidelines, maintaining product quality, and collaborating with multiple departments for batch release processes.

Key Responsibilities:

  • cGMP Compliance: Ensure adherence to current Good Manufacturing Practices (cGMP) at the site.
  • Material Dispensing & Sampling: Manage dispensing of raw materials (RM) and packing materials (PM) and sampling of products.
  • Line Clearance: Ensure proper line clearance before dispensing, manufacturing, filling, and packing of each batch.
  • In-Process Quality Control: Perform quality control checks during production, including checking environmental and personnel monitoring procedures.
  • Facility Cleanliness: Monitor cleanliness and verify equipment cleaning records as per SOPs.
  • Batch Documentation: Review and compile Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for submission to QA for batch release.
  • Coordination: Coordinate with other departments to collect reports and ensure smooth execution of work.
  • Regulatory Compliance: Ensure proper handling of QMS activities like Change Control, Deviation, and Incident reports.
  • Aseptic Processing: Ensure adherence to aseptic processing practices in sterile areas.

Competencies for the Role:

  • Knowledge of media fill simulation studies and filling BMR & BPR.
  • Strong understanding of current regulatory guidelines, cGMP, and GDP.
  • Familiarity with IPQA activities including dispensing, manufacturing, filling, and packing.
  • Experience in environmental and personnel monitoring procedures.
  • Knowledge of non-viable particle counting and equipment usage logs.
  • Experience in operating a portable non-viable particle counter.

Qualification and Experience:

  • Educational Qualification: B. Pharma
  • Experience: 2-3 years of experience in Quality Assurance, particularly in a pharmaceutical or medical device manufacturing environment.