Senior CSV Officer

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Job Description

JOB OVERVIEW

The Computerised Systems Validation (CSV) has responsibility for the management of on-site CSV activities, with a significant focus on GxP computerised systems.

Leading the CSV for GxP computerized systems, provide guidance, training to the site and ensure on schedule delivery of validation activities while managing vendor resources. To support in drafting of CSV artifacts, review and approval.

The role requires excellent coordination with clear and adaptable communication with external and internal stakeholders, such as Vendors, Clients, Quality, Project Management, Operations and Purchasing.

COMPETENCIES

• Strategic agility - Provides clarity and focus on key priorities to deliver on time and in full.
• Experience of Change Management - Effectively manages change by explaining the context, rationalising the requirement(s), answering questions and mitigating any issues.
• Proven project management skills - working with a variety of different systems and stakeholders to deliver commitments to the necessary quality standards.
• Decision making - Pushes decision making to the lowest appropriate level and develops employees' confidence in their ability to make those decisions.
• Relevant and demonstrable experience within the Pharma or Healthcare sectors.
• Excellent verbal and written communication skills are required, as well as a pragmatic approach with consideration to balancing business needs with compliance.
• A self-starter - does not wait to be told what to do.
• Ability to manage team and work independently, sometimes remotely with minimal or no supervision.

KEY RESPONSIBILITIES

• Manage Computerized system validation / re-validation and Infrastructure qualification activity for all GxP IT systems (HMI/PLC/SCADA/DCS/SaaS/IaaS etc).
• Preparation and maintaining CSV project plan and status tracking.
• Review of CSV deliverable documents received from vendor or prepared by internal IT / Quality team and provide inputs.
• To support and lead Digitization and automation projects of site quality / IT / Manufacturing processes where required.
• To participate in IT supplier audit and FAT of Equipment's/ Instruments used in GxP environment at site.
• To manage Computerized system inventory at site for GxP systems.
• To support/ ensure 21 CFR Part 11 and EU Annex 11 compliance at site for IT systems.
• Actively participate in Data Integrity assessments across the site, providing CSV input.
• Actively participate in Quality Risk Management, including gap analysis and remediation planning for GxP IT systems with Site Quality.
• Act as the Subject Matter Expert for CSV projects. To guide and train Site IT teams for CSV, Data Integrity and Regulatory IT Compliance activities.
• Review of IT related QMS documents e.g. Change control, Deviation, Incidents, SOPs, etc. as applicable in various capacity. Provide inputs for CSV.
• Timely closure of IT / CSV related Change control, Deviation, Incidents, CAPA, Observations at site.
• Constructively challenge deficiencies and inefficiencies.
• Support non-CSV validation activities when required, including:
  -Facilities
  -Utilities
  -Processes
  -Systems
  -Keep abreast of and maintain systems in line with changing regulations and industry expectations.
  -Participate in continuous improvement initiatives within Quality.

Qualifications

ESSENTIAL QUALIFICATION

A University Degree is preferred for this role, but not essential (experience dependent)

RELEVANT EXPERIENCE

• Experience in the pharmaceutical industry in a CSV role (CSV, Validation, Quality/ IT etc.).
• Excellent knowledge of validation of GxP computerized systems used at site, against the 21 CFR part 11 / EU annex 11 requirements.
• Strong CSV knowledge, particularly around IT GxP computerized systems validation as per GAMP guideline.
• Hands on experience on Trackwise, ENSUR (eDMS) implementation at site.
• Experience in Infrastructure and cloud server qualification as per guideline.
• Experience to support the Quality automation project (QMS processes).

About Us

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

About the Team

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.