GMP Compliance Analyst

EUR50000 - EUR60000 per annum
We are partnered with a Pharma who are seeking a experienced Quality Assurance professional to join them in Frankfurt

Purpose:
The GMP Compliance Analyst position is responsible for Quality Assurance and some Quality Control activities associated with compliance to Good Manufacturing Practices (GMP), the German Arzneimittel-und Wirkstoffherstellungsverordnung (AMWHV) and other applicable regulatory requirements and local laws, internal standards, and best industry practices in all aspects and processes within the unit. GMP Compliance personnel help to assure that packaging, labelling, storage and all other GMP related activities comply with requirements prior to product release.

Duties:
Review of Master Packaging Records as well as warehousing and room logs.
Provision of support for ongoing packaging projects in the Clinical Supplies Unit in form of in-process Quality Control.
Reporting of violations of GMP regulations via the appropriate channels and procedures, including re-training of Clinical Supplies Team.
Release of Logbooks for storage rooms, packaging rooms, cooling chambers, printers, etc;
Issue, control, and follow up on the complaint management, change control management, and the deviation management process.
Conduct with the annual self-inspection of the GMP facility as required by German AMG and reporting to Clinical Supplies Management / Executive Management.

Assistance with the creation and maintenance of the Site Master File for the GMP facility.
Support of validation activities for the GMP facility, e.g. for the cooling chambers.
Revision, maintenance and accessibility of procedural documents in the GMP facility.
Support the preparation, hosting and follow-up of client audits and Regulatory Inspections in the GMP facility.
Actively participate in training sessions and workshops, including presenting reports from any conferences attended.
Ensure timely completion and documentation of all training requirements.
Be aware of updates to regulations, guidelines and principles related to Good Manufacturing Practice (GMP) and advise on their use and compliance under the guidance of more Senior Management.

Ensure that systems and processes agreed by management and implemented will ensure that Clinical Trials have been performed and data is generated in compliance with GMP and other regulations.

Other duties, as required by the Quality Assurance department.

Requirements:
University Degree in a biomedical, pharmaceutical or related life science, nursing or engineering qualification beneficial
0–2+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
Ability to speak and conduct oneself in a professional manner
Desire and ability to learn and take on new tasks.
Diplomatic and professional oral and written communication skills.
Ability to proactively manage multiple tasks
Experience working in a team environment under time and resource pressures.
Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
If you are interested in this opportunity, please apply now with your updated CV in word/PDF format.
Notwithstanding any guidelines given to level of experience sought, we will consider candidates from outside this range if they can demonstrate the necessary competencies.

Square One is acting as both an employment agency and an employment business, and is an equal opportunities recruitment business. Square One embraces diversity and will treat everyone equally: Please see our website for our full diversity statement.

mehr...

zur Vakanz

Weitere Jobs von Aplitrak