Executive, Validation and Compliance

Job Description

Title: Executive, Validation and Compliance

Company Name: US FDA Approved Leading Pharmaceuticals Company

Vacancy: --

Age: At most 35 years

Job Location: Dhaka

Salary: Negotiable

Experience:

• At most 2 years
• The applicants should have experience in the following business area(s): IT Enabled Service, Pharmaceutical/Medicine Companies

• B. Sc. in Computer Science and Engineering (CSE) or relevant field.

• At most 2 years
• The applicants should have experience in the following business area(s): IT Enabled Service, Pharmaceutical/Medicine Companies

• Age At most 35 years

• 0–2 years of experience in IT Quality / IT Compliance role.
• Fresh graduates with strong compliance orientation may be considered
• Understanding of validation lifecycle activities, including IQ/OQ/PQ, validation protocols, test scripts, and validation reports.
• Knowledge of ERP, computerized systems, audit trails, user access controls, backup, and disaster recovery.
• Ability to prepare and maintain SOPs, change control records, deviation reports, CAPA documentation, and audit evidence.
• Strong analytical, documentation, communication, and coordination skills to ensure IT systems remain compliant with applicable regulatory and internal requirements.

• Provide day-to-day operational and administrative support for Quality Systems under supervision.

• Assist in User Management (creation, modification, deactivation) and maintain access records as per approved requests.

• Perform basic system checks, identify issues, and escalate to the system administrator when required.

• Support preparation, documentation, tracking, and follow-up of Change Requests (CRs).

• Maintain CR registers, status trackers, and supporting evidence in a controlled manner.

• Assist in preparation, formatting, coordination, and archival of Enterprise IT SOPs.

• Maintain SOP control logs, version histories, and distribution records to ensure document traceability.

• Support validation documentation activities (IQ/OQ/PQ), including evidence collection and test execution.

• Maintain validation trackers and controlled documentation repositories.

• Assist in audit preparation, evidence compilation, and response to audit queries.

• Support CAPA documentation, tracking, and status reporting for audit observations.

• Prepare routine IT reports, summaries, and compliance records, coordinating with cross-functional teams as needed.

• Perform other tasks and responsibilities as reasonably expected of the role and necessary in order to achieve the objectives of the organization.