Quality Assurance Specialist

Type of job: full-time

For my client, prestigious biotechnological company I am looking for Quality Assurance Specialist.

Position Summary

Participation in implementation, maintenance, development and monitoring of quality systems assuring compliance to GxP requirements.

Key Activities and Responsibilities

Owner of assigned quality systems

Review and approval of quality relevant documents (SOPs, validation documents, CAPA files, deviations, etc.)

Review and approval of risk analyses and documents related to computerized systems validation and surveillance

Coordination of risk analyses

Coordination of audits

Performing internal and external audits

Coordination of training, performing staff training on GxP topics

Participation in quality related projects

Responsibility for the management of databases for various quality systems (CAPA, deviation management, change management, risk management, audits, documentation management, training, validation, etc.)

Continuous self-education in GxP requirement and in manufacturing process

Competences, Skills and Qualification

Minimum Qualification- University degree – science

Advanced knowledge of English

Detail oriented person

General knowledge of quality systems in pharmaceutical manufacturing (cGMP)

Proficient in Microsoft Office: Word, Excel, PowerPoint, etc.

Autonomous, proactive, consistent person

Team player with good communication capabilities

Good organizational skills

Preferred Qualification

Experience in Quality Assurance

Knowledge of validation principles and experience in performing validation of computerized systems / equipment / analytical methods / process

Practical experience with risk management tools (FMEA)

Experience in project management

SharePoint knowledge

Other Requirements

Knowledge of ISO systems is an advantage

Offer

· Interesting work

· Very good salary

· Company benefits (e.g. bonus, pension contribution, 1 week extra holiday, sick days, multisport, meal vouchers etc.)

· Professional growth, good team

Start date is upon agreement.

In case of interest for more information, please contact Ing. Lada Drobišová, MBA (contacts are below).

In sending your CV you give your consent to processing and holding of your personal data in accordance with the General Data Protection Regulation (EU) 2016/679. regarding personal data protection by LD Human Resources s.r.o., ID: 24275336 until a written form revocation. Your personal data can be provided to third persons in order to obtain employment, namely after prior approval.

Contact:
Ing. Lada Drobišová, MBA

E-mail:
lada.drobisova@LDHR.cz

Telephone:
+420 722 950 102

Updated: 12.6.2019