Quality Validation & Data Integrity Supervisor (Pharmacist)

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Position:Quality Validation & Data Integrity Supervisor (Pharmacist)
Location:Nikom Amata City, Rayong

Report to:Head of Quality, Thailand (Thai)

Main product:Peritoneal Dialysis (Dialysis Fluid)

Job Scope:Responsible for leading site validation and data integrity activities to ensure compliance with regulatory requirements, industry standards, and company policies.

Job Responsibilities:

• Lead and execute the data integrity program for the site to ensure compliance with all regulatory requirements.

• Lead and execute the process and computer systems validation activities on site including defining the validation requirements and ensuring systems compliance to EU GMP Annex 11, 21 CFR Part 11, GAMP 5, along with the continuous regulatory expectations.

• Develop and write URS and run process and computerised systems validation project execution tasks including DQ/IQ/OQ/PQ in conjunction with relevant stakeholders, ensuring timelines are met and deliverables achieved.

• Proactively coordinate computerised systems validation and other validation activities and act as a central point of contact for the site for computerised systems validation and other validation to ensure the projects are delivered on schedule.

• Ability to translate local, corporate and regulatory computerised systems requirements into validation requirements.

• Perform risk management on computerised systems and other systems, assess the impact on compliance with EU GMP Annex 11, 21 CFR Part 11, GAMP 5, and translate the results into action and implementation plans to then execute.

• Act as process validation and Computer Systems/Software validation representative in both internal and external audits.

• Support and adhere to personnel policies and procedures.

• Plan and prioritise their workload to ensure that agreed deadlines are met.  This includes co-ordinating and performing computerised systems validation and other validation activities, tracking and reporting the progress of activities, anticipating and removing obstacles to progress,

• Provide periodic updates to the Computerised System Validation Manager, QA Manager and other relevant personnel.

• Train staff in computerised systems validation and other validation procedures and principles during execution activities.

• Adhere to Change Control Management System requirements for all changes to existing or implementation of new systems.

• Work in a safe manner and in compliance with Health, Safety & Environment mandatory policies, and procedures.

• Develop and provide training to employees on data integrity best practices and procedures.

• Collaborate with IT to ensure data integrity is maintained throughout system implementation and upgrades.

• Lead and participate in quality-related projects, including quality metrics development, quality dashboard creation, and quality process improvements.

Qualifications:

• Bachelor's degree in pharmacy.

• At least 3 years of experience in validation & data integrity, quality, or related field in the pharmaceutical or medical device industry.

• Proven experience in leading validation teams and executing validation protocols.

• Proven experience in leading and implementing data integrity programs.

• Strong knowledge of validation regulations, such as FDA, EMA, and GxP.

• Experience with validation documentation, including validation master plans, protocols, and reports.Excellent analytical, problem-solving, and communication skills.Ability to work collaboratively with cross-functional teams.

• Strong understanding of quality principles, such as Lean, Six Sigma, or Total Quality Management.

Benefit & Welfares:

• Housing & Transportation Allowance

• Canteen, Provident Fund, Group Life/ Health Insurance

• Fixed Bonus, Variable Bonus

• Etc.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.