IT Quality Assurance Specialist (Pharma/Manufacturing) (6 months contract)

Biocon; Gelang Patah; On-site; MYR 75,000 - 100,000; Full time

Job summary

A leading pharmaceutical company in Johor, Malaysia seeks an experienced IT Quality Assurance Specialist to oversee IT activities related to manufacturing systems. The role requires approval of key documentation, support on operating systems, and compliance with quality management systems. Candidates should have at least 5 years of experience in the IT and pharma industry, with expertise in computer systems validation and GxP compliance. Strong verbal communication and negotiation skills are essential.

Qualifications

• 5 years in IT and pharma industry with CS knowledge.
• Experience in Pharmaceutical organization.
• Expertise in implementing 21 CFR Part 11 and GAMP5 guidance.
• Ability to handle Qualifications Re-Qualifications.

Responsibilities

• Approve inventory list of Manufacturing system at Malaysia site.
• Review and approve IT related SOPs.
• Provide QA support on Operating system of computer systems.
• Ensure User Management and data management.
• Approve change control, deviation and CAPA in Trackwise.

Skills

IT and pharma industry experience

Computer Systems Validation expertise

GxP Compliance knowledge

Strong verbal communication skills

Experience in QMS management

Job description

IT Quality Assurance Specialist (Pharma/Manufacturing) (6 months contract)

Responsible for all IT related activities performed at Malaysia site as part of GOP implementation. Ensure QA oversight for the entire lifecycle management of CS with continuous tracking and monitoring. Expertise in handling QMS activities like change controls, Deviations and support as QA approver. Able to handle audits & inspections from HA’s.

Job Responsibility

• Approve the Inventory list of Manufacturing system including PLCs/ SCADA system installed at Malaysia site.
• Review/Approve IT related SOPs (As applicable for Manufacturing system including PLCs / SCADA.
• Approve qualification and validation of Manufacturing system including
• Approve of qualification and validation documents if Manufacturing systems including 21 CFR part-11 applicability, ER/ES, User& role management, software categorization and audit trail ETC..
• provide QA support on Operating system (OS) of computer servers, Desktops, Laptops, Industrial PCs and handled devices etc., which are used in Manufacturing systems including PLCs / SCADA system at Malaysia site).
• Ensure User Management (Creation, Modification, password reset), User access rights management on various drives, files and folders, Data and time management, OS policy management, Backup & restoration management, Installation / upgradation of operating system, OS service pack / patch management, Antivirus management (If applicable), periodic review of event logs (Where applicable).
• Ensure DGQA support for application software installed in computer system used for Manufacturing system at Malaysia Site. For example: User Management (creation, modification, password reset, User access rights management on various drives, files and folders, periodic review of security audit trails, periodic backup and retrieval of backed up data, upgradation of software, service packs, patches etc, provide assisted admin access to QA / regulatory authority during audits, provide support to external support team for fixing IT related issues during breakdowns.
• Perform the data and program backup and retrieval of Manufacturing system as per SOP.
• Review and approve of corrective action plan identified in Manufacturing system including PLCs / SCADA during internal / external audits.
• Approve of IT SOP, Change control, deviation and CAPA in Trackwise / BioQuest.
• Ensure Data export from OT systems and making it available for functional user’s process related analysis.
• Support of QMS as per IT operation requirements, investigation and CAPA implementation.
• Approval of SOPs as per process development requirements for information technology.
• Participate in internal and external audits to respond on IT related points for Manufacturing systems including PLCs/SCADA.
• SPOC for DGQA support and deliverables for day-to-day operational support, QMS, Audit readiness and IT compliance.

Qualifications

• 5 years in IT and pharma industry with CS knowledge and ability to drive, and ensure CS systems.
• Able to handle Qualifications Re-Qualifications wrt URS, IOQ, ERES and SW version updates.
• Experience in Pharmaceutical organization.
• Expertise in reasoning, Computer Systems Validation and GxP Compliance.
• Expertise in implementing 21 CFR Part 11, EU Annex 11, GAMP5 guidance.
• Experience managing internal/external audits and inspections.
• Strong verbal communications skills and negotiating skills with CFTs.
• Experience in QMS management, Quality metrics and reporting.
• Experience managing stakeholder expectations.
• Ability to deal with uncertainties and navigating through ambiguities.
• Experience in handling team and cross functional teams.