Senior Executive - CSV, IT

Job Description

Title: Senior Executive - CSV, IT

Company Name: Healthcare Pharmaceuticals Ltd.

Vacancy: --

Age: At least 25 years

Job Location: Dhaka

Salary: --

Experience:

• At least 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

Bachelor`s degree in Engineering from any reputed university, preferably in Industrial & Production Engineering or a related Engineering discipline

• At least 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Age At least 25 years

• Minimum 3 years of experience in Computer System Validation (CSV). IT Compliance, Software Validation, Quality Assurance, or Validation within pharmaceutical or other regulated industries.
• Experience in computerized system validation for ERP/SAP greenfield projects.
• Experience in handling regulatory inspections, internal audits, customer audits, and remediation activities for ERP/SAP process
• Strong knowledge of GAMP 5, GxP, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ principles.
• Knowledge of Change Control, CAPA, Risk Assessment, and Data Integrity practices.
• Excellent documentation, analytical, stakeholder communication, and project coordination skills
• Certification in Computer System Validation (CSV), GMP, GAMP 5, Quality Management Systems (QMS), Regulatory Compliance, or Information Security/IT Compliance will be an added advantage.
• Knowledge of SAP S/4HANA Manufacturing & Quality and pharmaceutical business processes will be an added advantage

Healthcare Pharmaceuticals Ltd. is one of the leading pharmaceutical companies in Bangladesh, certified by the international pharmaceutical regulatory authorities like EU GMP, TGA (Australia), NPRA (Malaysia), MCAZ (Zimbabwe). TFDA (Tanzania), EU GMP etc. To support our expansion program, we are looking for candidates who are interested to join our team for the mentioned position:

Job function: Computer System Validation (CSV)

Location: Head Office

Job Responsibilities:

• Coordinate end-to-end Computer System Validation (CSV) activities for SAP S/4HANA and other GXP computerized systems.

• Ensure compliance with GAMP 5, 21 CFR Part 11, EU GMP Annex 11, Data Integrity (ALCOA+) and other applicable regulatory requirements.

• Facilitate and support regulatory inspections, compliance audits, customer audits, and internal audits related to computerized systems.

• Ensure audit readiness by maintaining validation evidence, compliance documentation, and timely closure of audit observations and CAPA

• Conduct regular plant visits to support CSV activities, ensure IT and regulatory compliance, and maintain audit readiness.

We offer competitive compensation package, professional work environment and training and growth opportunities for the right candidate.