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Formulation Packaging and Operations

9.00 to 12.00 Years   Ahmedabad   10 Apr, 2020
Sygene
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Job TitlePacking Development and OperationsPositionAssociate ManagerRequired Educational QualificationM. Pharm or B.Pharm having 9-12 years of experience in pharmaceutical packing development and packing operations is required. Diploma in packaging operation from reputed packaging institutes will be an added advantage.Required work experience9-12 yearsJob LocationBangaloreRequired Skill setsExperience in Pharmaceutical Packaging and Operations & Manufacturing, Serialization Track & Trace.Knowledge of Packaging development, packing process validation, finalization of packaging change parts, evaluation of Packaging materials, and machinesJob PurposeResponsible for Supervision, documentation, upkeep, facility maintenance, cGMP compliance for packaging development and packaging operations at formulation manufacturing facility for human and animal health for oral solids, injectable and semisolids dosage forms.Primary Job Responsibilities

  • Experience in Pharmaceutical Packaging and Operations & Manufacturing, Serialization Track & Trace,
  • Knowledge of Packaging development, packing process validation, finalization of packaging change parts, evaluation of Packaging materials, and machines.
  • Change parts qualification, new packing equipment qualification.
  • Technical knowledge and hands on experience of operating of Blister packing machines like BQS, IMA PG, CAM NMX etc.
  • Technical knowledge and hands on experience of operating Bottle pack machines.
  • Technical knowledge and hands on experience of operating Cartonator - IC 150(IMA PG), CP150.
  • Technical knowledge and hands on experience of operating Printers such as Image, Videojet, Wolke printers.
  • Technical knowledge and hands on experience of operating Sachet/pouch packing.
  • To ensure Quality and compliance and facility readiness for client visit/ audits.
  • To ensure logbooks update, log sheets tracking and review of facility documents.
  • Experienced in regulatory compliance requirements (e.g. USFDA, MHRA, WHO, TGA).
  • Initiation of Change control for procedural revisions, changes in facility.
  • Procurement activity for consumables, instrument & equipment qualification.
  • Preparation of URS, review of DQ, IQ, OQ. Preparation & execution of PQ.
  • To ensure preparation & revision of SOP/IOP/EOP/ECC
  • Supervision, execution, planning & execution of clinical batches & registration batches manufacturing and packing activities.
  • To ensure cGMP training on a scheduled manner to all concerned personnel.
  • To ensure compliance to quality system procedures & documentation as per organizations requirements.
  • Hands on experience knowledge of Track-wise, SAP and Documents management system.
  • People management, Learning & training:
    • To review contract people daily work.
    • To ensure training to all on procedures.
Secondary Job Responsibilities
  • To ensure and implement procedures to target Zero Incidents.
    • To ensure preparation of Risk Assessment
    • To ensure proper Housekeeping and to circumvent EHSS Violations.
    • PPE compliance.
  • To support Project Execution.
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Keyskills :
regulatory compliancepharmaceutical packaging packaging developmentcontinuous improvement facilitation change controlquality system

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