Job Description
Title: Executive/ Senior Executive, Quality Operations
Company Name: ACI HealthCare Limited
Vacancy: --
Age: 23 to 35 years
Location: Narayanganj (Sonargaon)
Minimum Salary: Negotiable
Experience:
∎ 2 to 4 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies
Published: 14 Oct 2024
Education:
∎ Master of Pharmacy (M.Pharm), Master of Science (MSc) in Chemistry, Biochemistry, Applied Chemistry
Requirements:
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.
∎ 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)
Company Information:
∎ ACI HealthCare Limited
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 31 Oct 2024
Category: Medical/Pharma
