Senior CSV / Validation Specialist

As a recruitment company, DCG understands that every business is powered by experienced professionals. Our management style and partnership approach enable us to meet your needs and provide continuous support. Due to our ongoing growth and the large number of recruitment projects we undertake for our partners, we are currently looking for:

Senior Validation Specialist

Responsibilities:

• Determines validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerized systems

• Responsible for the review of software documentation according to CSV corporate SOP's, and regulatory guidance

• Author validation plans/reports, reviews test plans/reports (and other deliverables) to assess and notify that system is ready to go life

• 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

• Assess changes to determine potential impact to the validated state of the computerized system

• Support system maintenance with validated state and permanent audit readiness

• Lead and author system periodic review according to procedure

• Provide input and guidance for a computerized system retirement planning

• Coordinate and advise on all validation activities on a global level/organizational level for system/project

• Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards

• Participate actively in validation discussions, provide consultancy for all validation related questions

• Assures strategic/essential oversight over validation support within the department and provides support/consultancy for the team and within the global organization if necessary

• Support system audit/inspection preparation and execution as CSV subject matter expert

• Observe governance processes, escalates area for improvement

• Prepares recommendations for process optimization in his/her area of influence

Requirements:

• 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment

• Mandatory Experience in Lean and/or Agile approaches

• 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 maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11

• Demonstrates proficiency in gSuite

• Demonstrates basic knowledge of SAP and MES systems and the interfacing thereof

• Hands-on experience with Retina or JIRA (Backlog Management)

• Hands-on experience with ServiceNow (Incident, Change, Knowledge Management)

• Aware of common development technologies and governance processes impacting validation approaches

• Professional Scrum or SAFe Certification is an advantage (will be mandatory to be obtained within 6 months after joining)

• Collaborate closely with Product Owner, Scrum Master, Architects, Developers, Business Owners and Tester Team (Leads)

• Ability to work collaboratively in cross-functional teams to achieve milestones and goals

• Communication skills, English language mandatory (C1)

• Demonstrates ability to explain complex concepts with clarity and simplicity

• Demonstrates strong verbal, written, and interpersonal communication skills

• Assertiveness, conflict management skills, leadership skills

• Follow-through and persistence: our team is globally spread and some key stakeholders, due to extremely busy schedules, will need chasing up for input/signatures

• Ability to share knowledge and guide others

Offer:

• Private medical care

• Co-financing for the sports card

• Training & learning opportunities

• Constant support of dedicated consultant

• Employee referral program