Site Name: Bengaluru Luxor North Tower
Posted Date: May 24 2023
ACCOUNTABILITIES AND KEY RESPONSIBILITIES:

• Represent CSQA as a business contact.
• Execute effective processes and procedures in CSQA & GQA and may contribute to business processes and procedures outside GQA.
• Ensure computer systems meet regulatory requirements and that they conform to regulatory expectations.
• Represent CSQA and participate in the review and approval of computer system documentation throughout the lifecycle of an application.
• Review and approval of change requests through to closure of computerized systems and infrastructure as applicable.
• May interact with regulators during regulatory inspections and provide relevant documentation as required.
• Support routine computer compliance vendor audits (internal & external) as well as computer compliance initiatives.
• Participate and collaborate in CSQA initiatives, programs, or team activities, as required.
• Identify and mitigate computer related business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
• Contribute to improvement processes, as needed, and set specific measurable targets and goals linked to CSQA/GQA/GSK business needs.
• Contribute to the training, education, guidance and influencing of GSK R&D (Research & Development) staff on best quality and computer compliance policy and practices.
• Ensure compliance with computer compliance regulations and expectations in alignment with GSKs related policies and procedures.
• Eliminate regulatory risk to GSK facilitating the right level of validation activities necessary to deliver the solution to industry standards and regulatory requirements
• Mitigate computer compliance risks to GSK via providing advice and consultancy to GQA project teams and business units regionally and globally within R&D

• Maintain awareness of, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance within and across departments.
• Consult with Manager with any questions, concerns, or project related risks.
• Any other duties relevant to, and consistent with, the job's level of responsibility, as required by CSQA management.

SKILLS & COMPETENCIES

• Demonstrable knowledge/awareness of the regulated pharmaceutical industry and computer compliance regulations and expectations
• Participation in hands on implementation (1-2 years at a minimum), of one phase of the CS (Computerized Systems) lifecycle of applicable industry standards in the software development lifecycle model, aligning with the Quality and Regulatory expectations for the industry.
• Communications are clear, concise, well structured, authentic, and easily understood. Communicates and interacts at most levels both inside and outside of GSK.
• May influence and negotiate at various levels within the organization.
• Build and maintain effective internal GSK business relationships within GQA and business units.

GSK is a global biopharma company with a special purpose ? to unite science, technology and talent to get ahead of disease together ? so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns ? as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it?s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We?re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in ?gsk.com?, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.