Job Ref. ID:
Specialist - CSV
Quality Assurance - Qualification & Validation
UNITED ARAB EMIRATES
UAE (RAK head office)
Full Time Employment (Limited Contract)
Job Summary/ Main Purpose
Specialist – CSV the role holder is responsible to provide support and direction to business and project teams in Software Development Life Cycle (SDLC) / Computerized System Validation CSV standards and practices. Ensures that all GxP computerized systems used for supporting Manufacturing, testing, facility maintenance are appropriately validated and controlled as per the standards. Responsible to ensure that the standalone manufacturing, analytical and engineering systems are tested for access control, audit trail, functions and backup files/records by coordination with validation team.
Key responsibilities & Accountability:
Responsible for improvement and to ensure compliance of computer system validation and IT quality compliance procedure to meet the Julphar policies and procedures.
Prepare and review of Validation deliverables like URS, SVP, QRA, GxP assessment, FRS, DS, FRA, IQ, OQ, PQ, RTM, Data migration script and SVR etc.
Perform and lead computer system validation projects related to authoring and executing specifications/scripts and validation documentation for computerized processes/equipment/systems in production and laboratory areas according to the GAMP5 Validation Life Cycle/USP 1058
Conduct and execute validation activities for IT- GxP and Engineering computerized systems like EMS/BMS, DAS Systems and water systems etc.
Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols
Responsible for preparation, review and closure of test incidents/defects and its status reporting
Perform periodic review of the GxP systems to ensure that they continue to remain validated
Work with equipment owner(s) and process owner(s) to ensure the initiation and implementation of project pre-requisite like URS, change control and quality risk assessment activities etc. are in accordance with site/department procedure
Handle of Computerized system related QMS like deviations, change controls and CAPA’s etc.
Responsible to prepare and maintain the computerized system inventory for all Julphar sites/departments
Responsible for management CSV validation documents like archiving, retrieving and distribution
Prepare, review and execute of spreadsheet validation documents
Co-ordinate with external agencies for execution of qualifications and re-qualifications.
Responsible for operation and calibration of validation instruments.
4 years Bachelor Degree in Computer Science / Engineering is mandatory
At least 5-6 years’ experience in pharmaceutical industry in computer system validation sections, out of which 3 years’ experience in core pharmaceutical manufacturing plant is preferred.
Strong knowledge of regulations, such as 21CFR Part 11, Good Automated Manufacturing Practice (GAMP5), GEP, Good Automated Laboratory Practice (GALP) and cGMP.
Knowledge of regulatory guidelines relevant to Annex 11 and 21 CFR Part 11 compliance requirements, and ISPE GAMP guidelines are required
Solid understanding of Computer Systems Validation of Manufacturing, Quality and Engineering systems
Fluent in English & Arabic (communicating, writing and speaking).
Proficient in MS Office (MS Excel and MS Word, etc.).
In terms of competency you are highly result oriented with strong sense of accountability & ownership.
High on process compliance and implementation skills with strong attention to details.
Strong communication, interpersonal and problem solving skills required.
Business acumen partnered with a dedication to legality.
Must be able to manage tasks and priorities and easily adapt to changing situations.
Highly disciplined and must be organized, self-motivated to learn new learnings and implement them at workplace
Must be able to work in a cross-functional environment interacting with other internal and external departments
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