Quality Analyst - Fixed Term Contract Bucharest

Quality Analyst - Fixed Term Contract
Bucureşti
Bucharest, Bucharest, Romania

The opportunity

As a Quality Specialist you will be responsible of implementing and maintenance of Good Manufacturing Practice (GMP) compliance, batch certification, and review of quality system documentation.

How you’ll spend your day

• Inspection Readiness: manage and support regulatory inspections as a team member/SME or lead auditor in conducting audits (internal or external) including preparation of audit report responses to authorities. Participate actively in Shopfloor Quality oversight program. Required experience in EU/FDA regulatory inspections.

• Data integrity for the site: Required knowledge about ALCOA+ and DI principles (such as data protection, segregation of duties, audit trail).

• Contribute to the Implementation and maintenance of Quality Management Systems (CAPA, Complaints, Deviations/Out-of-Specification, Change control System Organization): Required experience with Veeva and Track
Wise systems.

• Organization, Approval and Verification of the corrective and preventive actions, complaint, deviations,
-
- specification results and change control system 

• Monitoring the timely and correct implementation of corrective and preventive actions proposed as a result of process deviations, controlled changes, or
- conformities identified during internal/external audits.

• Verification of the effectiveness of corrective/preventive actions or issuance of a protocol to determine their effectiveness

• Investigation of
- related complaints, including corrective and preventive actions

• Identify Quality Deficiencies, report to Quality Unit Management and ensure are resolved in a timely manner, in accordance with internal procedures.

• Support for Other Departments in Quality Assurance Activities to ensure compliance.

• Issuance, verification, and/or approval of documentation related to the compliance with corporate standards and verification of documents according to current procedures (master OPs, standard operating procedures, controlled changes, deviations, risk assessment sheets, investigation reports, quality specifications, analytical methods).

• Prepare, analyze and communicate quality metrics to the site leadership and above site functions.

• Active role in communicate findings and sharing best practices for continuous improvement.

Your experience and qualifications

• Fluent verbal and written communication in English and preferably additional other languages (i. e French, Italian, Spanish)

• Ability to simplify processes, identify bottlenecks and translate stakeholder feedback into clear processes.

• Active listener and
- making skills.

• Teamplayer with strong analytical and critical thinking approach.

• Knowledge on OPEX and implementation of time management tools (i. e. Daily Tier meetings, workplan boards).

• Minimum 2 year experience on Quality Unit in Pharma Industry or minimum 5 years experience in Quality Control laboratory or in production is required.