Quality Systems Specialist – Quality Assurance

This is a fully remote position, open to applicants anywhere in the world.

📋 Description

• 🎯 In your daily responsibilities, you will:

• Facilitate the development, review, and upkeep of production records within the MES system, aiding in adherence to Good Manufacturing Practices (GMP) and regulatory standards.

• Ensure the integrity of master data through effective manufacturing processes and collaborate with cross-functional teams to ensure that Master Batch Records (MBRs) fulfill both business and regulatory criteria.

• Analyze and resolve technical deviations linked to electronic production systems, with an emphasis on supporting investigations pertaining to the MES system.

• Track performance metrics and suggest or lead continuous improvement initiatives for the system and its related processes.

• Identify technical deficiencies and recommend training in partnership with the Training department and management to foster team growth.

• Serve as a liaison between technical teams and users, translating complex information, facilitating change management, and promoting a holistic view of the production chain integrated with SAP and LIMS.

• Offer technical assistance for the execution and upkeep of post-implementation governance processes.

• Provide technical support during audits and inspections concerning the MES system.

• Represent the system sustainment/support segment (post-implementation) to the project team, sharing operational insights, key considerations, and improvement prospects to aid the ongoing development of solutions.

⛳️ Requirements

• 📝 To engage in our process:

• A Bachelor’s degree in Computer Science, Computer Engineering, Automation Engineering, Software Engineering, Information Systems, Information Technology, or related fields.

• ⭐ You will be favored if you possess:

• Experience with MES systems, particularly PAS-X.

• Knowledge of system integration.

• Prior experience in a pharmaceutical setting.

• Familiarity with databases, integration with SAP and LIMS, and principles of data integrity.

🏝️ Benefits

• Meal voucher;

• Food allowance;

• Libbs Medication Program – 100% coverage;

• Pharmacy agreement – Vidalink;

• PPR – Profit-Sharing and Results Participation Program;

• Parking, commuting allowance or company shuttle (applicable for shift work and subject to availability of routes serving areas within a straight-line radius of up to 40 km from the site);

• USE Program: subsidy to purchase the device to be used for work, which may also be utilized for personal purposes;

• Flexible benefits (TotalPass, life insurance, private pension, health insurance, dental care, and meal assistance).