Senior QA Compliance Specialist

Band

Level 3

 

Job Description Summary

The Complaint Specialist is responsible for performing complaint investigations (initial assessments, escalations, investigations and approval) and it is responsible for identifying improvements of complaints across all products.

Additionally, there is the responsibility regarding the management of samples and all related activities.

All these tasks are to be performed while ensuring GxP compliance of all relevant quality systems, as well as keeping high health & safety standards.

 

Job Description

Major Accountabilities

Accountable for investigating technical and mixed product complaints.

Accountable for the quality of the investigations.

Responsible for coordinating the actions of different departments to complete the investigations.

Responsible for prioritizing the workload to meet deadlines.

Support for the approval and closure of complaints.

Accountable for the sample management process.

Responsible for identifying improvement opportunities and support implementation.

Support the standardization of the complaint processes and the implementation of the process for new products.

Support the complaint team in preparing for internal/external audits.

Responsible for keeping complaint procedures and work instructions up-to-date with current regulation and global procedures/quality manuals.

Support the communication between complaints and key stakeholders.

Support in training new employees of the complaints team.

Support other functions as required.

Key Performance Indicators

Maintaining the Key Quality Indicators associated with the Complaints Department (on-time completion, effective CAPAs, extension rate, etc)..

Education

Degree in the natural sciences (pharmacy, chemistry, medicine, biology, microbiology).

Experience

Experience in the field of manufacturing medicinal products for human use; work experience in the field of GMP production/Quality Assurance or Quality Control; good knowledge of MS office applications and other standard IT applications. Must be capable of setting priorities and working under pressure. Ability to work well with internal and external participants is essential.

Language

Fluent in English and German ideally.

Impact on the organization

Ensuring the GMP guidelines in the assigned area of responsibility.

Specific Professional Competencies

Ease of use with office software. Structured work ethic. Goal oriented and transparent. Team player. Excellent communication skills across all levels in the organization. Can motivate colleagues to work towards common goals. Oriented towards problem-solving & logical thinking. Demonstrates high level of accountability and ownership.

 

Skills Desired

Action-Oriented, Compliance Requirements, Continued Learning, Dealing With Ambiguity, Functional Skills, Gmp Procedures, Gxp, Industry Standards, Process Optimization, Qa (Quality Assurance), Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence