Job Description
Title: Asst. Manager, Maintenance - (For Pharma Plant)
Company Name: Dider Pharma Limited
Vacancy: Not specific
Job Location: Bogura
Employment Status: Full-time
Educational Requirements:
∎ BSc/M.Sc in Mechanical/Electrical
Experience Requirements:
∎ 5 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
∎ Only males are allowed to apply
∎ Experience (minimum 5-7 years) in pharma field.
∎ 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-solving skills.
∎ Strong issue-tracking and issue-management skills.
∎ Communication, teamwork, and team leadership skills.
∎ Excellent documentation and communication skills.
∎
Salary: Negotiable
Compensation & Other Benefits:
∎ Salary Review: Yearly
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 6 Jan 2024
Company Information:
∎ 7 Dec 2023
∎ Dider Pharma Limited
∎ Address : Kukrul, Darial Road, Hazradighi, Bogura
Category: Engineer/Architect
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