Validation Lead

Validation Lead

Ttms Software Sdn Bhd
Selangor
3-13 years
Not Specified

Job Description

Requirements:
- 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
- Experience in leading validation for projects and systems maintenance
- Experience in authoring validation plans, reports and deliverable registries
- Experience in authoring or reviewing validation related deliverables, records and other evidences
- Experience in software development lifecycle processes (SDLC), models, standards in
pharmaceutical industry (or other regulated)
- Experience in Lean and/or Agile approaches
- Experience in maintenance and support of applications under global inspection agencies
- Aware of common development technologies and governance processes impacting validation
approaches
- Ability to work collaboratively in cross-functional teams to achieve milestones and goals
- Ability to communicate clearly and professionally both in writing and verbally
- Ability to share knowledge and guide others
- Ability to make sound decisions about quality and technical subjects
- Higher education degree or relevant work experience in computer science, software engineering, information systems and/or pharma industry
- Communication skills, English language mandatory (C1)
- Assertiveness, conflict management skills
- Ability to attend meetings in EU/US time zone from time to time
Responsibilities:
- Determines validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerised systems
- Responsible for the review of software documentation according to CSV corporate SOP's, and regulatory guidance
- Provide estimates and forecast validation activities for a project
- Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and
notify that system is ready to go life
- Determine testing strategy, requirements and acceptance criteria
- Liaison with business quality/informatics quality to ensure compliance with corporate quality
policies and standards
- Coordinate and advise on all validation activities on a global level/organizational level for
system/project
- Participate actively in validation discussions, provide consultancy for all validation related
questions
- Participate in system implementation and maintenance planning
- Lead and author system and functional risk assessments
- Verification of testing plans, activities, deliverables and records, provide consultancy on test
related deviations and corrective actions
- Review and collect expected CSV deliverables, records and other evidences according to plans
- Prioritize activities in line with the project schedules, business needs and compliance
requirement
- Ensure code release to production and maintenance procedures are identified and adhered
- Confirm initial data loading and/or data migration from other systems, are performed according
to approved procedures
- Assess changes to determine potential impact to the validated state of the computerised system
- Support system maintenance with validated state and permanent audit readiness

TTMS Software Sdn Bhd is one of the companies included Transition Technologies - Managed Services Sp. z o.o.

We specialize in outsourcing IT professionals, including the leasing team - we offer the entire project teams with a dedicated Team Leader. Our activities cover all the processes connected with creation, development and maintenance of the systems which we take full responsibility for. Thanks to it Customers minimize their total cost of solution maintenance (TCO) simultaneously protecting themselves from the risk of problems with access to resources necessary for the right maintenance and development of IT systems used in a certain area of business activity.

Among our customers there are world leaders from sectors like: automatic control, energetics, transport, industry, healthcare, banking. Our teams are involved in projects where they create from the very beginning, implement and develop very often innovative solutions that support our customers' core business activities, as well as optimizing the number of business processes.

By entrusting the implementation of key projects, our customers can quickly and efficiently achieve their business goals.

We are constantly expanding our team, join us!

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