Associate

Line of Service

Assurance

Industry/Sector

Not Applicable

Specialism

Assurance

Management Level

Associate

Job Description & Summary

A career in our Controls Assurance practice, within Internal Audit services, will provide you with an opportunity to gain an understanding of an organisation’s objectives, regulatory and risk management environment, and the diverse needs of their critical stakeholders. We focus on helping organisations look deeper and see further considering areas like culture and behaviours to help improve and embed controls. In short, we seek to address the right risks and ultimately add value to their organisation.

Our team helps business leaders gain comfort that their systems, processes, and risk management procedures are operating effectively within a well controlled environment. We focus on helping clients make sure they have adequate controls in place to mitigate key risks, maintain key processes that enable management to make appropriate decisions, and ensure that an effective risk management framework is in place in case of a system breakdown.

Position Title: Associate

Grade/Level:

Reporting Manager Title:

Job Code:

LoS: Assurance – SPA – Computer System Validation

Sub LoS/SBU: SPA

Location:

Position Type: (Permanent full-time, Permanent part-time, Fixed term contract, Internal secondment)

Job Summary (Please include a couple of lines on the firm and LoS)

About Assurance services:

Firm's Assurance Services provides assurance on the financial performance and operations of a client’s business, helps businesses improve external financial reporting and adapt to new regulatory requirements as per state laws/international standards. The Assurance group can also help organizations report externally on non-financial information, strengthen its corporate governance procedures, and achieve social and economic goals related to corporate sustainability. Financial audits provide an independent opinion on a company's financial report and are a critical element in the capital markets system.

ABOUT SYSTEMS & PROCESS ASSURANCE SERVICES:

The Systems and Process Assurance (SPA) practice in Price Waterhouse, provides both audit and non-audit services related to controls around the financial reporting process, including financial business process and IT management controls.

SPA provides:

•  Financial and operation applications/business process controls reviews
•  Database security controls reviews
•  IT general controls reviews
•  Infrastructure security reviews
•  Third party assurance and opinion services
•  Sarbanes-Oxley readiness, process improvement and sustainability services
•  Compliance with other regulatory requirements (e.g., Turnbull, Basel II, King)
•  Due diligence on systems and controls
•  Pre- and post-implementation systems reviews
•  Project assurance services
•  Data services (e.g., CAATs, data quality reviews)
•  Computer security reviews

Roles & Responsibilities (essential functions and responsibilities of the job):

• Identify and manage regulatory risks to support client in regulatory compliance, governance and controls.

• Lead and coordinate cross-functional project teams for validation projects to include reviews, risk analysis and other activities in support of systems development.

• Author validation strategies and other plans and protocols and summary reports (end-to-end computerized system validation experience is mandatory).

• Plan, manage and execute as needed, installation, operational and performance qualifications in accordance with current Good Manufacturing Practices (cGMP's).

• Candidates must demonstrate expertise in ISPE GAMP5, ICH Q8, ICHQ9, ICH Q10 and 21 CFR part 11, Computerized System Validation, Equipment Qualification and Validation Change Control

• Proficient in Microsoft Word, Excel, Power Point, SharePoint, Visio and Project.

• For Manufacturing CSV Expert specifically, must possess knowledge of system alarms and recipes; and have experience in both Software Validation as well as integrated equipment-software qualification tests to demonstrate robustness of controls in place.
• For Laboratory CSV Expert specifically, must possess prior experience in validating standalone laboratory systems. For Empower 3 CSV Expert specifically, must possess prior experience and knowledge in validation and implementation of Empower 3 across the network, custom field creation and validation, and training module creation and implementation.
• For Clinical system experts, should have strong knowledge on Clinical trial processes as per GCP regulations, like eCTD, CTMS, Adverse event reporting tools, etc.,
• For Enterprise System Validation experts – Should have knowledge on enterprise system landscape / architecture, validation methodologies. Strong Validation skills on SAP, QMS Software’s, LMS, LIMS, Email tools, Web portals, Microsoft office tools, Excel Spread sheets, Infrastructure Qualification (Servers, Desktops, Network etc)
• Should have strong expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, 21 CFR Part 11, and Annex 11).
• Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and Quality Assurance groups to assure successful project execution and end-user training
• Author and Review of validation lifecycle documentation
• Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions
• Provide Quality review and assessment of associated change requests related to processes, IT infrastructure, equipment’s and computer system
• Manage project governance, including providing progress updates of the assigned deliverables, driving timely closures of escalations and facilitating strategic decisions with senior management
• Should have strong expertise on Data Integrity Audits

Qualification & Desirable Experience:

• Minimum 10 years of experience in GMP regulated environment working on Computer System Validation with a strong knowledge on Global GMP and CSV regulations and guidance.
• Bachelor’s degree/Master degree in Engineering, Computer Science, Information Technology, Computer Applications, Life Sciences, Biotechnology, Pharmacy, MBA (IT) and related fields. Preference will be given to candidates from premier institutes/ well recognized institutions
• Strength in several lead competencies-Think Strategically, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers and Make Decisions
• Willingness to travel domestic and internationally/across client locations, with a prior notice of 1-1.5 weeks.
• Must not be involve in any legal issues/ offences and eligible to work in INDIA.
• Must be willing to work on direct client facing roles and handle the Validation and GMP tasks as per the Engagement letter.
• Must be willing to travel to any client location for projects for defined number of months / years, as per the client contract.
• Must be willing to support in internal business development activities. Should have strong knowledge on Proposals, Efforts estimation and Project Planning and delivery.

Candidate Specifications (insert the relevant personal skills here):

Desirable Skills:

• Communicate with Impact & Empathy
• Develop Self & Others through Coaching
• Build & Sustain Relationships
• Be Passionate about Client Service
• Be Curious: Learn, Share & Innovate • Lead & Contribute to Team Success
• Demonstrate Courage & Integrity
• Acquire and Apply Commercial & Technical Expertise
• Manage Projects & Economics
• Be Open Minded, Practical & Agile

CV sifting criteria (definitive criteria which a CV must have. This helps us to screen out irrelevant CVs):

The skills we look for in future employees (This is standard text that is incorporated into every job description.  You do not need to add any content into this field.  This is for your information only):

All our people need to demonstrate the skills and behaviours that support us in delivering our business strategy. This is important to the work we do for our business, and our clients. These skills and behaviours make up our global leadership framework, ‘The Firm Professional’.

The Firm Professional focuses on five core attributes; whole leadership, business acumen, technical capabilities, global acumen and relationships. We use this framework to recruit, develop and assess our people, at all grades and all areas of our business, because we expect all of our people to be leaders.

Education (if blank, degree and/or field of study not specified)

Degrees/Field of Study required:

Degrees/Field of Study preferred:

Certifications (if blank, certifications not specified)

Required Skills

Optional Skills

Desired Languages (If blank, desired languages not specified)

Travel Requirements

Not Specified

Available for Work Visa Sponsorship?

No

Government Clearance Required?

No

Job Posting End Date