Validation Consultant Job at CONVAL (Istanbul)

Associate Lead Consultant - Validation Testing

The GxP System Administrator is responsible for the day‑to‑day administration of...

Location

India , Bangalore

Salary:

Not provided

YASH TECHNOLOGIES CONSULTING INC.

Expiration Date

Until further notice

Requirements

10+ years
Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field (or equivalent experience)
Experience administering GxP‑regulated or compliance‑critical systems
Familiarity with data integrity principles and regulatory expectations (e.g., 21 CFR Part 11, Annex 11)
Experience with access control, configuration management, and system monitoring
Strong attention to detail and documentation skills
Ability to work cross‑functionally and manage multiple priorities

Job Responsibility

Manage user access, roles, and permissions in accordance with approved procedures and the principle of least privilege
Ensure timely provisioning, modification, and deactivation of user accounts
Periodically review access to confirm continued appropriateness and compliance
Perform and document system configuration activities in alignment with approved configurations and change control processes
Maintain system settings that support data integrity, audit trails, and regulatory requirements
Support implementation of approved system updates, patches, and configuration changes
Monitor system health, audit trails, and security events to ensure ongoing compliance
Identify and escalate potential compliance issues, deviations, or risks
Support periodic system reviews and continuous compliance activities
Support change control activities by providing system impact input and execution support

What we offer

Flexible work arrangements
Free spirit, and emotional positivity
Agile self-determination, trust, transparency, and open collaboration
All Support needed for the realization of business goals
Stable employment with a great atmosphere and ethical corporate culture

It Validation Consultant (Pharma)

Take your career to the next level with Amaris Consulting as a IT Validation Man...

Location

Spain , Barcelona

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Degree in Business Administration, Computer Science, or comparable professional experience
Around 4 years of experience proven experience in validation within a GxP-regulated environment, preferably in an IT area
Strong knowledge of GAMP5 (v2) principles and their practical application
Ability to quickly learn and manage system lifecycle documentation (e.g. Validation Plan, URS, Functional Specifications, Risk Assessments, Test Reports, AAP, etc.)
Experience in developing and delivering training on KBs and SOPs aligned with the Validation Plan and AAP
Familiarity with ITIL v4 is considered an advantage
Excellent written and spoken English
Proven ability to work effectively in a virtual, international, and multicultural environment
Strong organizational, analytical, and problem-solving skills, with a results-driven mindset
Excellent communication, collaboration, and stakeholder management skills

Job Responsibility

Ensure that all validation activities are properly planned and executed in accordance with validation strategies, GxP requirements, and applicable SOPs prior to system go-live
Maintain the validated state of the system throughout its entire lifecycle
Collaborate closely with Quality Assurance (QA) on compliance-related topics
Coordinate with System Owners, Process Owners, Business Process Owners, System Leads, Developers, and other key stakeholders
Ensure that all system-specific SOPs and System Lifecycle (SLC) documentation are in place before system operation
Oversee testing activities, including review and approval of executed test cases
Provide audit support and maintain up-to-date system documentation and presentations
Manage and resolve system discrepancies in collaboration with global system roles
Drive continuous improvement by optimizing and simplifying validation processes using risk-based approaches

What we offer

Tailored career path and salary evaluation
Tech Academy catalog, Udemy E-learning Platform, Language Sessions, webinars, and workshops
Annual personal training budget and company-paid certifications
Flexible policies, remote work options
Transit and restaurant tickets
Kindergarten support
Private health insurance
WeCare program supporting employees in critical situations

Fulltime

Csv Specialist / Csv Consultant - Mes Validation

Location

India , Hyderabad

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

5+ years of experience in Computer System Validation (CSV)
3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments
3+ years of hands-on experience with MES validation and GxP validation lifecycle
Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations
Experience in validation document preparation, review, execution, and approval workflows
Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams
Strong documentation discipline and attention to detail

Job Responsibility

Validation Plan and Validation Risk Assessment
Requirement Traceability Matrix
IQ, OQ, and PQ protocols
Executed test scripts with objective evidence
Deviation, defect, and issue logs with closure evidence
Validation Summary Report
Approved validation package supporting MES go-live readiness

Fulltime

CSV Specialist / CSV Consultant - MES Validation

We are looking for experienced CSV resources to support a Manufacturing Executio...

Location

India , Hyderabad

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

5+ years of experience in Computer System Validation (CSV)
3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments
3+ years of hands-on experience with MES validation and GxP validation lifecycle
Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations
Experience in validation document preparation, review, execution, and approval workflows
Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams
Strong documentation discipline and attention to detail

Job Responsibility

Support validation planning, impact assessment, risk assessment, and validation strategy for the MES scope
Prepare and review validation documents such as Validation Plan, URS, FRS, DS, RTM, IQ, OQ, PQ, and Validation Summary Report
Prepare, review, and execute validation test scripts with objective evidence as per approved procedures
Log, track, investigate, and support closure of deviations, defects, and validation observations
Validate MES workflows, master data, recipes, electronic batch records, equipment integration, interfaces, and user roles
Ensure alignment with GxP, 21 CFR Part 11, EU Annex 11, ALCOA+, data integrity, and internal quality standards
Maintain end-to-end traceability from requirements to testing and final validation closure
Work closely with MES functional team, technical team, QA, manufacturing SMEs, automation, and business users
Ensure validation deliverables are complete, controlled, and inspection-ready

Fulltime

New

Clinical Director Laboratory - Divisional

The Clinical Director of the Laboratory for Midlands Division directs one or mor...

Location

United States , Columbia

Salary:

Not provided

MUSC Health

Expiration Date

Until further notice

Requirements

Bachelor's degree in medical technology or Allied Sciences
Certification as a MT (ASCP registered)
5 years of management experience in a hospital setting
Knowledge of state, federal (CLIA), and Joint Commission regulations
Certification as a MT (ASCP registered)

Job Responsibility

Directs one or more major functional areas of a department, a department, or a business unit
Manages two or more professional and support staff including subordinate managers
Directs the analysis, planning, implementation, and expenditures and budget tracking of major operational projects or initiatives
Provides recommendations to the leaders throughout the organization
Leads in developing strategies and implementation plans to improve and standardize all aspects of operations
Ensures that reports of test results include all pertinent information required for interpretation and that meet regulatory compliance
Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions
Directs the strategic initiatives of the laboratory addressing communication with internal and external customers for a timely response to new clinical service trends and program planning
Maintaining effective reimbursement processes through coding reviews and support to Charge Services with current best practice billing definitions
Advise, negotiate, manage and administer all contracts into which the lab may enter

Fulltime

New

Senior Plant Engineer

At Argenta, we’re more than a company — we’re a global team, dedicated to health...

Location

United States , Shawnee

Salary:

Not provided

Argenta

Expiration Date

Until further notice

Requirements

5+ years working experience in cGMP environment
Knowledge in Pharmaceutical regulations
Bachelors degree in engineering discipline
Pharmaceutical background prefer sterile manufacturing experience with knowledge in pharmaceutical regulations

Job Responsibility

Makes independent decisions within defined areas of responsibility
Serves as a consultant to management within a specified areas/discipline
Advance technical project proposals to senior management, following through successful completion
Influences commitment of resources at divisional / departmental level
Continuously improve and support existing production equipment to support the efficient operation of the Argenta production facility
Manage capital projects, develop and track budgets
Interface with internal and external resources to facilitate the transfer of process knowledge to the manufacturing environment
Ensure that all Engineering activities within the area of responsibility adhere to all applicable engineering standards, codes, cGMP’s, FDA and EU guidelines, safety and environmental procedures
Reviews and approves standard operating procedures describing validation principles and activities
Participate with completing risk analyses for qualifications and validations with participation of Quality, Production and MEU

Fulltime

New

Senior Manager, Strategic Planning - Broker Strategy (Aetna International)

The Sr. Manager, Strategic Planning – Broker Strategy owns the design, evolution...

Location

United States , Hartford

Salary:

67900.00 USD / Year

CVS Health

Expiration Date

July 04, 2026

Requirements

A minimum of 7 years of experience in strategy, go-to-market/commercial planning, channel strategy, management consulting, or related roles
Demonstrated understanding of broker-led (or partner-led) distribution models and how to translate channel insights into actionable growth initiatives
Strong structured problem-solving and judgment
able to frame issues, evaluate options/tradeoffs, and drive decisions in a matrixed environment
Highly effective communicator with proven ability to craft executive-ready narratives and materials that distill complex information into clear, concise, and actionable insights
Analytical skillset with experience defining success metrics, interpreting performance data, and using insights to improve strategy and execution
Proven ability to influence without authority and lead cross-functional workstreams through ambiguity with strong ownership and follow-through
Coachable, growth-oriented mindset with a commitment to continuous improvement
Bachelors degree preferred or a combination of education and work experience

Job Responsibility

Own Aetna International’s broker growth strategy and annual plan, aligning priorities, investment choices, and timelines to enterprise and regional goals
Define and maintain broker segmentation, targeting, and tiering
translate market intelligence and performance insights into differentiated value propositions
Define and operationalize cross-sell strategy with domestic (U.S.) business partners, identifying priority segments, aligned value propositions, and coordinated broker plays to drive growth across Aetna’s domestic and international portfolios
Develop broker-specific GTM plays and campaigns with clear success measures and accountable owners
Create executive-ready narratives and decision materials (problem statements, options, tradeoffs, and recommendations) to drive alignment and timely decisions
Partner with Sales Support and Marketing to deliver broker communications, training, playbooks, and tools
ensure consistent adoption across teams
Coordinate with Product to ensure broker needs and feedback inform roadmaps, packaging/pricing considerations, and launch readiness for broker-relevant capabilities
Establish the broker strategy operating rhythm: planning cycles, stakeholder forums, action tracking, and cross-functional follow-through

What we offer

Medical, dental, and vision coverage
Paid time off
Retirement savings options
Wellness programs

Fulltime

!

New

Senior Regulatory Affairs Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Degree in Pharmacy preferred
+3 years of experience in pharmaceutical, medical device or health industry
Experience in regulatory affairs or relevant discipline is preferred
Solid understanding of drug development
Good knowledge of National Drug Regulations and Procedures
English Proficiency
Good communication skill for external and internal interaction
Good computer literacy skills, comfortable working with database

Job Responsibility

Achieve timely & successful product registration in accordance with corporate & local strategies
Collect any information on new regulations and guidelines and share it in local RA team
Ensure compliance with company regulatory policies, regulations and procedures
Design and assess local regulatory plans including new strategic concepts and license opportunities and provide consolidated input on key regulatory development in cross-functional team meeting
Manage all regulatory tasks & projects including attaining, maintaining product licenses and operations licenses for assigned portfolio on behalf of company as required by local regulations
Prepare and submit regulatory applications for assigned portfolio and ensure timely approval
Develop local registration plans in alignment with local business and global regulatory strategy
Monitor progress of submission & coordinate timely responses to all questions from health authorities
Be compliant with Corporate Policies, Regulations & Procedures, in particular implementation of current Company Core Data Sheet (CCDS), Change Review Committee (CRC) and local change control procedures
Management of regulatory submissions to support clinical trial activities

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Select Country

Validation Consultant

Job Description

Job Responsibility

Requirements

Looking for more opportunities?