Job Description
Title: Asst. Manager- DBL Digital (For Pharma Plant)
Company Name: DBL GROUP
Vacancy: 1
Job Location: Gazipur
Employment Status: Full-time
Educational Requirements:
∎ Bachelor of Science (BSc) in CSE, ETE,IT
Experience Requirements:
∎ 4 to 7 year(s)
Job Responsibilities:
∎ Collaborate with cross-functional teams to develop validation strategies and plans for various computer systems used in our operations.
∎ Execute validation protocols, including installation, operational, and performance qualifications, to ensure systems are meeting predefined specifications.
∎ Identify and document deviations, and collaborate with relevant teams to implement corrective and preventive actions.
∎ Maintain thorough and accurate validation documentation, including test scripts, reports, and validation summaries.
∎ Participate in risk assessment activities to identify potential system vulnerabilities and implement measures to mitigate risks.
∎ Assist in training employees on the proper usage of validated computer systems and adherence to validation-related procedures.
∎ Support audits and inspections by providing validation documentation and participating in discussions related to validation processes.
∎ Pharma Documentation: Create and update Pharma related all documentation like (SOP, EOP, MOC, RA, CAPA, Report, Deviation etc.)
∎ Collaborate with internal and external stakeholders to identify training.
∎ Prepare reports on training activities, participant feedback, and program effectiveness.
∎ Need good knowledge of Master Control and LIMS.
∎ Experience with Oracle technologies or related areas is considered advantageous and a plus point.
Additional Requirements:
∎ Age at most 35 years
∎ Experience (minimum 4-5 years) in CSV field. While pharmaceutical experience can be a plus point.
∎ MBA from a reputed university will be a plus point.
∎ Certification in validation (e.g., CSV, CSEP) is a plus.
∎ Proven experience in computer system validation, including creating validation plans, protocols, and reports.
∎ Familiarity with regulatory guidelines such as FDA 21 CFR Part 11, GAMP 5, and EU Annex 11.
∎ Strong analytical skills with the ability to troubleshoot and identify deviations in system performance.
∎ Strong analytical and problem-resolution skills.
∎ Strong issue-tracking and issue-management skills.
∎ Communication, teamwork, and team leadership skills.
∎ Excellent documentation and communication skills.
∎ Certification in validation (e.g., CSV, CSEP) is a plus.
Salary: Negotiable
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 9 Dec 2023
Company Information:
∎ 28 Nov 2023
∎ DBL GROUP
∎ Address : South Avenue Tower (6th Floor), House No # 50, Road No # 03, Gulshan Avenue, Gulshan 1, Dhaka - 1212
Category: IT/Telecommunication
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