Kennziffer der Stelle
Operations — Engineering
5 bis 10 Jahre
AKKODIS is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation.
As part of the development of the activities at one of our clients, we are looking for a Development Quality Lead.
What are your responsibilities ?
The job holder will ensure that quality and compliance issues are managed with diligence, rigor and transparency in all CMC activities supporting product and process development, clinical supply
manufacturing, analytical work, technology transfer, CMC filing, … from early phase to commercial launch of the product, to ensure product quality, compliance to regulatory requirements, within the business performance expectations.
Key Responsibilities :
Proactively provide guidance and advice to PS and/or BTS Project Technical & Supply Team (Project TST).
Ensure that CMC project related QA activities are consistent
Review and approve adequate documentation made available and followed for CMC development
Ensure quality oversight on TST decisions that frame-up CMC strategy and documentation package
for late stage development
CMC regulatory submissions (IND/IMPD)
Coordination of and oversight on the Quality Assurance group members
Ensure progressive transfer of product and process control strategy documents to Global Quality Lead
CMC regulatory filing activities for product registration (BLA/NDA/MAA)
Ensure that all operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, OSHA, DEC, etc. where relevant).
Actively participate in identifying, developing and implementing local quality and operational
- Minimum 7 years experience in pharmaceutical
- Must be knowledgeable in QA and technical requirements of (Bio)Pharmaceutical development processes,
- A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
-Experience in partnering with Development stakeholders and coordinating different QA functions towards business objective achievement
-Experience in conducting customer / vendor audits and participation in the management of regulatory inspections including PAI.
-QA/compliance experience in IMP manufacturing, facility operation, laboratory compliance and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical services, and an in-depth knowledge of at least one scientific discipline related to (Bio)pharmaceutical sciences.
- Experience with solid and liquid dosage forms, sterile parenteral and/or Biological product manufacturing quality assurance or development.
- Must have strong, organization and analytical skills.
- Must be fluent and English, other languages are an asset.
- Good knowledge of cGMP and product development regulatory requirements (eg US,
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