Senior QA GMP Specialist

In the frame of a 6 months CMC project (possible extension), we are looking for a seasoned Consultant specialized in QA GMP to join a leading pharmaceutical company based in Brussels.

Location: Walloon Brabant

Duration: 6 months (possible extension)

Scope of work:

Operational

- Ensure the CMC PROJECT related QA ACTIVITIES are consistent across the range of different environments and teams supported (Vendors/Suppliers/in house)
- Ensure adequate documentation processes and systems are available and followed for CMC development projects (SOPs/Protocols review/approval)
- Proactively support the activities of CMC and Clinical supply QA for relevant manufacturing quality systems.
- Advise CMC development sub-teams and the wider CMC community in order to assure regulatory compliance and ensure scientific consistency across CMC development projects.
- Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions
- Partner with project teams to address operational deficiencies identified by regulatory Agencies.

Process

- Ensure that all operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, OSHA, DEC, etc. where relevant).
- Support the head of CMC and Clinical supply QA in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies.
- Actively participate in identifying, developing and implementing local quality and operational excellence improvements.

Internal & external contacts

- Interacts with CMC Product Development team as the primary QA liaison.
- Interacts with local Analytical and Microbiological Services, Operations, Regulatory Affairs and project management to effectively communicate requirements and expectations.
- Other QA Teams.
- FDA, EMEA, and other regulatory authorities.
- Member of industry/QA associations.
- Contract manufacturing, development and testing organisations.

REQUIREMENTS:

- Academic background as a QUALIFIED PERSON (QP), master in chemistry or doctor in chemistry.
- 4-5 years' experience in chemical pharmaceutical development .
- Expertise in chemical synthesis and formulation.
- Must be fluent in English, other languages are a bonus.
- Good knowledge of cGMP and relevant regulatory requirements (eg US, European, Japanese).
- Familiarity with risk analysis techniques (good risk awareness).
- Good interpersonal, verbal, and written communication and presentation skills are required.
- Must have strong organization and analytical skills.
- Autonomous and with good teamwork skills.
- Immediately available.

Keywords: QP, QUALIFIED PERSON, QA, GMP, CMC, QUALITY ASSURANCE