TRD QA Specialist

Description

You will join the QA team at the Pilot Plant in Colleretto Giacosa, which is in ramp-up and needs a local Quality function for IT and OT systems.

The role supports the set-up of a compliant quality system for GMP-relevant IT, OT, computerized and automated systems used in manufacturing, QC laboratories, facilities, utilities and supply chain.

During the ramp-up you help qualify and validate these systems, document their lifecycle, write procedures and check interfaces, equipment connections and data integrity. Once operational, you keep them compliant, secure, fit for use and validated.

Success is measured by timely qualification and release of these systems to project timelines, timely completion of validation deliverables, periodic reviews, deviations, CAPAs, changes and access reviews, and audit or inspection outcomes with no critical QA-related gaps.

Responsibilities

• Act as the local QA expert for GMP-relevant IT and OT systems, giving independent quality oversight while supporting cross-functional work during the ramp-up.
• Review and approve validation and qualification deliverables, including URS, risk assessments, validation plans, test protocols, executed test evidence, deviations, and qualification or validation summary reports.
• Make sure global applications, local systems, infrastructure, equipment software, interfaces and data flows are assessed, qualified and released before GMP use.
• Clarify who is responsible for what among system owners, users, IT, OT, Engineering, Quality and support functions across the system lifecycle.
• Oversee controls for user access, audit trails, electronic records and signatures, backup and restore, archiving, business continuity, system security and data integrity.
• Review and approve changes, deviations, CAPAs and risk assessments that affect GMP-relevant computerized systems.
• Coordinate periodic reviews that confirm systems stay compliant, supported, secure, fit for use and validated.
• Help draft, review, approve and maintain GxP procedures covering validation, system administration, access management, audit-trail review, backup and restore, incident management, change control, periodic review and system retirement.
• Support internal audits and Health Authority inspections that involve computerized systems, data integrity, automation, electronic records and signatures.
• Drive continuous improvement, including streamlining validation work and applying risk-based quality practices suited to the Pilot Plant's operational maturity.
• Model the company's culture, values and behaviours within QA and with cross-functional teams.

Requirements

• Show experience in several of these areas: computerized-system validation and qualification, IT quality and eCompliance, OT and industrial automation, pharmaceutical manufacturing and laboratory systems, data integrity, electronic records and signatures, IT infrastructure qualification, system lifecycle and periodic review, change, deviation and CAPA management, supplier and service-provider oversight, audit and inspection support, quality management systems, and GxP documentation.
• Have at least three years of proven experience in pharmaceutical or similarly regulated industries, in QA, computerized-system validation, laboratory computerized-system support, manufacturing automation, IT/OT quality or a comparable role.
• Know GxP and computerized-system expectations such as EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and data-integrity guidance.
• Have hands-on work with IT, OT, computerized, automated, manufacturing or laboratory systems in a regulated environment.
• Understand computerized-system lifecycle management, qualification, validation, quality systems and data-integrity principles.
• Have prepared, reviewed, executed or approved qualification and validation documentation for computerized systems.
• Understand system architecture, interfaces, data flows, infrastructure dependencies, equipment connectivity and electronic records.
• Have worked with electronic quality systems for change control, deviations, CAPAs and related processes.
• Bring a strong quality mindset, ownership, analytical thinking and the ability to work well in cross-functional teams.
• Take a proactive approach and look for ways to improve.
• Speak Italian and English at intermediate level or above.

Conditions

Base salary range is €29,800 to €55,300 per year.

Pay is set under the company's pay policy using gender-neutral criteria such as skills, competencies and experience, and is reviewed periodically after joining.

The position is based at the Pilot Plant in Colleretto Giacosa, with flexible and hybrid working where possible.

Equal opportunity: the company values diversity and treats all applicants equally.

Benefits

• You may be eligible for a performance-based bonus.
• Benefits in kind include insurance plans, retirement plans, wellbeing resources and global recognition programs.
• Minimum 14 weeks of paid parental leave.