[Hiring] Senior Quality Specialist @Indotronix International Corporation

Role Description

The Computer System Quality Assurance Team provides quality oversight of business enterprise technology within the Pharmaceutical Services Group (PSG) of Client, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data integrity, computer system lifecycle activities, and adherence to PSG QMS systems. We support a global business network across multiple time zones, collaborating with global Quality, IT, and business groups to support multi-functional projects and continuous improvement initiatives. We share and implement standard methodologies within our assigned project scope and oversight of PSG corporate technology.

We are seeking an IT centric quality individual with a critical thinking mentality, able to adapt and work with a diverse variety of individuals, demonstrable understanding of corporate technology implementation and operational maintenance for enterprise SAP instances and the associated lifecycle management both for infrastructure and applications. The candidate should utilize a risk-based approach, able to influence and vitally provide clear direction to teams and leadership.

In addition, the qualified individual must possess strong CSV expertise. This includes knowledge and understanding of:

• GAMP 5
• 21 CRF part 11
• EU Annex 11
• 21 CFR 820 (QMSR)
• 21 CFR 210
• 21 CFR 211

This individual will collaborate with System and Business Process Owners to meet business and regulatory requirements that are inclusive of system design, validation, implementation, and lifecycle management.

Our desired candidate has a Bachelor's Degree, or higher, in Science, Engineering or QA/Regulatory related course of study, has direct pharmaceutical experience (QA, QC, or Regulatory Affairs), and is an effective collaborator who can develop an internal strategic network while working remotely. Prior experience with SAP compliance is strongly preferred. The candidate must have a clear understanding of risk in computerized systems and be able to communicate actions, compliance gaps, and commitments to respective areas, including senior leadership. 5 years of experience preferred in a similar role.

Qualifications

• Bachelor's Degree or higher in Science, Engineering or QA/Regulatory related course of study
• Direct pharmaceutical experience (QA, QC, or Regulatory Affairs)
• Effective collaborator with the ability to develop an internal strategic network
• Prior experience with SAP compliance (strongly preferred)
• 5 years of experience in a similar role (preferred)

Requirements

• Strong CSV expertise
• Knowledge of regulatory requirements related to validation, computer systems, and data integrity
• Ability to contribute to a demanding and evolving work environment across multiple time zones
• Strong decision-making capabilities
• Proficient in Microsoft Office Suite
• Effective at multi-tasking and responding to shifting priorities

Benefits

• This position is remote and will not require travel
• High-speed internet access required
• Ability to connect to Teams meetings