2022-07-29 11:26:48

Quality Assurance Specialist

CVMarket.lt klientas
1900 - 2200 €/m Gross

Job Description

We are currently looking for a Quality Assurance Specialist for our manufacturing site in Vilnius. Main purpose of the role: ensure Company’s GMP compliance with regulated activities The person will be directly reporting to Quality Assurance Manager

 

• Batch release documentation management;

• Work with international Teva team related to Drug Products (DP) testing and release;

• Review batch manufacture protocols, analysis protocols, Manufacturing Site & Technologies (MS&T) protocols;

• Investigation and troubleshooting of laboratory, manufacturing deviations corrective and preventive actions, complaints and change control Management; 

• KPIs management, collaboration with Quality Control (QC) for products cycle time management;

• Stability review and documentation management;

• QC Computerized Systems Audit Trail review.

Requirements

• University degree qualified in pharmacy or natural sciences (biology, biochemistry, biotechnology); 

• Previous work experience with regulatory requirements, work in laboratory, manufacturing, work with international team;

• Work experience in TW DB, EDMS Glorya, SAP N20;

• Projects/process management experience is an advantage; 

• Ability to work on multiple projects and tasks;

• Proven ability to effectively collaborate with internal and cross-functional teams, as well as external parties, in a fast-paced and complex environment;

• Strong analytical skills;

• Strong drive for results;

• Exceptional interpersonal skills and good judgment;

• Flexible, dynamic, highly energetic and very well organized;

• Highly proficient in the following software programs: (Word, Excel, PowerPoint, databases).

• Fluent Lithuanian, very good English written and verbal communication skills

Company offers

• Salary range of 1900 - 2200 Euro gross monthly

• Benefits package: health and accident insurance, additional health and vacation days (for worked years)

• Highly professional team and organizational culture with strong values

• Personal and professional development within the company

• Work model supporting work life balance

• Employee rewards and recognition programs, events and social activities

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