Quality IT Systems Lead

Job Description

Business: Piramal Pharma Solutions

Department: Quality Assurance

Location: Sellersville, PA

Travel: N/A

Job Overview

The incumbent is expected to provide Quality oversight and direction to site-based Quality projects. The Quality IT Systems Lead will serve as a liaison between the site and corporate quality management (Information Systems).
They will highlight and resolve site computer quality issues and promote communication at the site, serve as a site trainer, when required, seek ways to improve the site Quality IT/IS and computer automation work processes. They will support the implementation of the Piramal computer validation strategy at the site and supply them with information about lessons learned from the IT & Quality Corporate group to promote consistency.

Essential Duties & Responsibilities

Compliance Monitoring and Review: The objective of the Compliance Monitoring and Review Function is to provide oversight to ensure consistent use of Policies, Standards, Procedures, Guidelines, etc relating to computer system development, operation, and maintenance.

• Provide Quality Review and approval (Quality signatory) on all regulatory site-based computer system documentation, as required by Piramal SOP's.
• Provide oversight to ensure consistent use of Policies, Procedures, Standards, Guidelines, etc. relating to computer system development, operation and maintenance.
• Coordinate site-based compliance audits of documentation repositories. Conduct site-based in-process audits of the Piramal SOP's deliverables for projects.
• Ensure that site repositories for computer validation and maintenance documentation are developed and maintained.
• Review and approve (or ensure review and approval of) System Life Cycle documents, specifications (user, functional, and detailed design) and SOPs, as required. Provide expertise to operations in the evaluation of process, equipment and software applicability, as required.
• Ensure that site repositories for computer validation and maintenance documentation are developed and are maintained.

Computer Project Support: The objective of the Computer System Project Support Function is to provide site management of quality computer systems projects.

• Provide consultation, quality oversight and expertise for site Quality IT and other computer system projects. The coordinator must be able to translate the regulations (e.g. 21CFR Part 11) and regulatory terms and intent into language that is understandable and meaningful to the customer/system owner.
• Provide computer system project support.
• Assist in the assessment of required project resources and scheduling.
• Manage outside contractors used to perform automation services for specific projects, as required.
• Assist in developing cost estimates for site Quality IS projects, when required.
• Develop and track schedules for site Quality IS projects from inception through completion.

Data Integrity: To ensure IT Compliance (includes 21 CFR Part 11) at site for GxP systems.

• Define Site specific SOPs for IT systems and ensure compliance there of - e.g. CSV, Periodic review, Audit trail review, Backup/restore, etc.
• Define validation strategy and review of validation deliverables QC/Manufacturing systems e.g. PLC/SCADA, GC, HPLC etc.
• Provide support (to Corporate QeC) for site specific projects rolled out by Corporate IT team e.g. Trackwise, Ensure, LMS, SAP, etc.
• To collaborate with Site DICO and IT SPOC for Data integrity compliance for IT systems.
• To investigate incidents/deviation or data integrity issues for IT systems and define RCA and CAPA accordingly.
• Conduct trainings and awareness about CSV and IT Compliance requirements/processes for site teams
• To attend Governance meetings for IT updates and Collaborate with Corporate QeC to ensure adherence to corporate standards and guidelines
• Perform periodic and audit trail review of IT systems at site to measure compliance to SOPs
• Front end client and regulatory audits for CSV / IT Compliance related data requests and provide compliance to the observations, if any.

Communication: The objective of the Communication Function is to coordinate all Quality IT activities at the site.

• Coordinate all Quality IT activities at the site.
• Implement and manage site activities in accordance with the Quality IT strategic plan.
• Work with the Information Technology Department, Operations Labs and Engineering to identify practical procedural and technical solutions to problems, to plan, and oversee implementation, validation activities for Laboratory information and automation systems.
• Ensure consistent interpretation and communication of Piramal policies, standards and procedures.
• Ensure the timely and accurate dissemination of information to and from the sites to the corporate WW Quality group.
• Effectively interface with multiple levels of management while communicating consistent departmental goals and objectives
  Guidelines and Standards Review: The objective of the Guidelines and Standards Review Function is to support alignment of internal guidelines, procedures, standards, and policies.
• Review site system validation programs and make recommendations to ensure that their programs meet the current standards, requirements and current GMP's.

Improvement Planning: The objective of the Improvement Planning Function is to increase computer compliance within sites and across sites, through sharing of best practices and lessons learned within the SQC Network.

Qualifications

• B.S. in Chemistry or related science
• 3 years of related laboratory experience
• The incumbent must possess specific knowledge in the following areas: Quality practices and processes, metrics development, project management, automated system validation, data integrity, security, electronic records, and electronic signatures within a regulated environment. Automated systems (Pharmaceutical automation systems) a plus.
• Knowledge of current industry expectations of validation requirements for software and equipment validation / qualification
• Technical ability to problem solve and troubleshoot equipment systems in a pharmaceutical environment
• Able to make difficult decisions and push them forward to completion. Able to execute despite resistance and unexpected obstacles.
• Positive attitude toward changes in the work environment with a commitment to constant improvement.
• Experience training analysts and a commitment to helping them improve.
• Strong computer skills including MS Office.

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.