Quality Assurance Specialist Timişoara

Quality Assurance Specialist
Timişoara
Timişoara, Romania

Quality Assurance Specialist

Place of work: Timișoara

Contract: Fixed-term contract for 2 years

As Quality Assurance Specialist you are part of the Quality Assurance Department in Medicines Control Laboratory, in close coordination with other functions and departments.

Requirements:

• University degree in pharmacy, chemistry, or a related field;
• Previous experience in quality assurance, experience within the pharmaceutical industry is an advantage;
• Familiar with hardware/software and IT configuration;
• Knowledge of computer applications or other computer systems;
• English advanced level.

Responsibilities/Tasks:

1. Analytical Documentation Management

• Draft and distribute analytical procedures for new molecules;
• Update internal procedures based on supplier documentation for existing molecules;
• Draft and submit Certificates of Analysis for approval;
• Keep records of analytical documentation;
• Approve Excel file validation documentation for GMP data processing.

2. Quality Management System (QMS) Implementation

• Implement global procedures at the local QMS level;
• Develop and manage key QMS documents (quality manual, standard unit file, SOPs, work instructions);
• Maintain and update QMS documents, including distribution, archiving, and destruction of expired documents;
• Organize records for all specific documents and ensure controlled distribution;
• Initiate and propose updates to QMS documents based on necessary changes;
• Ensure QMS process compliance for assigned processes;
• Participate in the audit team for self-inspections;
• Fulfill any assigned quality assurance tasks from the Head of QA Department;

3. Substitution and Reporting

• Substitute for another QA department employee when needed;
• Compile and submit reports and information to management regarding QA activities within deadlines.

What we offer:

• Attractive salary package;
• Bonuses for Easter, company birthday, Christmas;
• Performance bonus;
• Transport allowance;
• Meal vouchers;
• Private medical insurance;
• Modern working conditions with a young and dynamic team.