Job Description
Title: Executive- Validation
Company Name: DBL Pharmaceuticals Ltd.
Vacancy: --
Location: Gazipur
Experience:
∎ 1 to 4 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies
Published: 1 Apr 2024
Education:
∎ Bachelor of Pharmacy (B.Pharm) in Pharmacy
∎ Bachelor of Science (BSc) in Electrical & Electronic Engineering
∎ Bachelor of Science (BSc) in Chemistry
Requirements:
Additional Requirements:
∎ Proficient in Microsoft Word, Excel, Power Point and knowledge of other QMS software is a plus.
∎ Experience in ERP system and other data analysis will get advantages.
∎ Strong knowledge of GMPs guideline /GLP/GDP/ regulations (WHO, UKMHRA, FDA, 21CFR part 11 etc.)
∎ Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
Responsibilities & Context:
∎ To develop Validation Protocol, Qualification Protocol & Reports.
∎ Responsible for performing the validation of Utility systems, Facilities & Processes.
∎ Qualification / Validation of process machinery (Granulation, Compression, Coating, Blister & Sterile manufacturing equipment etc).
∎ Temperature mapping for all storage area (warehouse, cool room, cold room, Stability chamber etc).
∎ Transport validation activity to be performed as per regulatory requirement.
∎ Scheduling, planning, managing and executing studies for cleaning validation.
∎ Documentation of validation protocol, Calibration report, Trend analysis report, SOP & others related to regulatory audits.
∎ Coordination Validation activities with other departments like development, Manufacturing, Engineering, Quality, Third Parties, and other groups on validation projects.
∎ Preparation of Hold Tine Study report and schedule to monitoring the activity.
∎ Supporting the development of best and proven validation practices in the validation department, based upon current industry guidelines and practices.
∎ Handling of QMS Process related with validation.
∎ Participate in validation and qualification activities in coordination with Validation team.
∎
Workplace:
∎ Work at office
Employment Status: Full Time
Job Location: Gazipur
Company Information:
∎ DBL Pharmaceuticals Ltd.
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 15 Apr 2024
Category: Medical/Pharma
