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Ztmp Qa - Ipqa

Zydus Healthcare Limited
Zydus Healthcare Limited
3+ years
Not Disclosed
10 Feb. 17, 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

Job Title: ZTMP QA - IPQA
Location: Manufacturing - API, Gujarat, India
Posted: Feb. 12, 2025
Employee Type: C-C8-Confirmed-HO Executive
Experience Range: More than 3 years
Qualification: M.Sc Chemistry

Job Responsibilities:

  • Perform activities under the IPQA (In-Process Quality Assurance) function.

  • Maintain soft copies of scanned master batch record folders for routine issuance activities.

  • Preparation, issuance, and control of labels for drug substances & drug intermediates.

  • Generation and affixing of approved and rejected labels on respective containers.

  • Review batch records, cleaning records, and electronic data parameters in LIMS.

  • Perform batch record review and ensure closure of observations before batch release.

  • Conduct usage decisions (batch release) of approved batches in LIMS and SAP.

  • Provide line/equipment/area clearance for manufacturing, packaging, and repacking/relabelling activities.

  • Handle and ensure activities for rejected or failed materials as per procedures.

  • Support repacking/relabelling activities.

  • Ensure compliance with SOPs.

Requirements:

  • Total Experience: More than 3 years

  • Qualification: M.Sc Chemistry

  • Key Skills: Knowledge of IPQA processes, LIMS, SAP, Batch Records, SOPs compliance.

This role offers an opportunity to be part of a quality assurance team in the API manufacturing industry. If you meet the qualifications and experience, this could be a great next step in your career!