Executive/ Senior Executive, Quality Operations

ACI HealthCare Limited

ACI HealthCare Limited

 

ACI HealthCare Limited

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Summary

  • Vacancy: —
  • Age: 23 to 35 years
  • Location: Narayanganj (Sonargaon)
  • Minimum Salary: Negotiable
  • Experience: 2 to 4 years
  • Published: 14 Oct 2024

 

Requirements

Education

  • Master of Pharmacy (M.Pharm), Master of Science (MSc) in Chemistry, Biochemistry, Applied Chemistry

Experience

  • 2 to 4 years
  • The applicants should have experience in the following business area(s):
    Pharmaceutical/Medicine Companies

Additional Requirements

  • Age 23 to 35 years

Responsibilities & Context

  • Develop and validate analytical methods in support of R&D product development.
  • Develop and validate analytical cleaning methods in support of Cleaning Validation / Verification.
  • Provide analytical technical support of R&D product development.
  • Provide IPQA support for Production Operations.
  • Perform relevant physical characterization of pharmaceutical products by development of discriminating dissolution methods.
  • Perform RLD evaluation, including reverse engineering principles.
  • Perform API characterization and raw material testing, including chemical and physical tests utilizing both Vendor methods and USP/NF monographs.
  • Troubleshoot, calibrate and maintain analytical instrumentation.
  • Write experimental protocols, summary reports, analytical methods, SOPs.
  • Maintain appropriate documentation (records and lab notebook) for all processes, observations and results as per SOPs and test methods.
  • Learn new techniques and solve complex analytical problems.
  • Perform training for team members.
  • OOS investigations and develop appropriate action plans to deliver innovative solutions and definitive root cause analysis.
  • Compile and submit ANDA, PAS, CBE 30 and other supplement.
  • Interact effectively with multi cross-functional teams and work closely with other departments for preparation of regulatory filings.
  • Comply with lab SOPs, GLP, GMP, and company safety requirements.
  • Perform investigation deviation, market complaint and Incident.
  • Perform self-inspection and external vendors audit.
  • Perform other related duties as assigned to meet departmental and company objectives.

Workplace

Work at office

Employment Status

Full Time

Job Location

Narayanganj (Sonargaon)

Source link

To apply for this job email your details to admin@chakricircular.com