Quality Assurance Associate – Master Data

Description

The company is a healthcare business working across Innovative Medicine and MedTech, developing treatments from the lab through to patients.

This Quality Assurance Associate role for Master Data is based in Latina, Italy, and sits in the Quality Assurance area, which checks that product quality meets specifications and GMP and other applicable regulations.

The team is looking for the best talent for the role.

Responsibilities

• Approve production documentation, including Master Batch Records and recipes, and master data for materials, equipment and resources, keeping timelines and quality on track, monitoring cycle time, and working with the global group that approves master data.
• Check and manage critical master data under GMP and the company's quality and compliance procedures, and secure its approval.
• Act as the site's Quality contact on cross-functional project teams for New Product Introduction, Technology Transfer, Technical Launch and Validation Process so product launch dates are met.
• Support quality processes, including nonconformity management, tracking corrective and preventive actions, and Change Control requests linked to assigned projects.
• Resolve issues across plant departments involving products, processes, equipment, facilities and utilities, to protect quality, safety and efficacy.
• Represent QA on company projects and look after their quality aspects.
• Serve as Subject Matter Expert for Data Integrity, ensuring data is handled correctly across system capabilities and its review and approval process.
• Approve GMP documents for computer systems and equipment, make sure only qualified or validated systems are used with proper documentation, and manage deviations.
• Give effective support to Production, providing solutions in critical situations.

Requirements

• Master's degree in Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biology, Engineering, Computer Science, or an equivalent qualification.
• 12 months of experience in the pharmaceutical industry or a similar field.
• Excellent English.
• Good working knowledge of the Office suite.
• Preferred: knowledge of MES systems, ideally PAS-X, and SAP.
• Preferred skills: accountability, administrative support, compliance management, attention to detail, document management, execution focus, goal attainment, human-centred design, internal controls, process orientation, quality control (QC), quality management systems (QMS), quality standards and report writing.

Conditions

Fixed-term contract of 12 months.

Based in Latina, Italy, with a hybrid work model.

Anticipated base pay range is €30,400.00 to €49,450.00.

Successful candidates must complete country-specific checks before starting.

The company respects diversity and treats each person as an individual.

Benefits

• Annual bonus with a set target (% of pay) that depends on pay grade and location, based on individual and company performance in the previous calendar year, or sales commissions.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave and volunteer leave.
• Well-being reimbursement and programmes for financial, physical and mental health.
• Service anniversary and recognition awards.
• Insurance plans for employees and, in some locations, eligible dependents, subject to plan terms.
• Benefits information is for guidance only; amounts and benefits may vary by location and may change.