Interim CMC Quality Assurance Specialist
South of Sweden | KonfidentielltInterim Search has been appointed to recruit an interim CMC Quality Assurance Specialist to a global Medtech Company in the south of Sweden.
Responsabilities and main tasks:
- Provide support to the CMC Department in Good Manufacturing Practices (GMPs) with significant operational and quality experience
- Drive process and product quality through CMC quality systems, ensuring adequate supplier oversight/surveillance
- Document and initiate change control, perform quality investigation reports in company´s quality management system
- Provide strategic planning input and continual improvement measures focused on records processes, reporting/escalating critical quality issues
- Manage, maintain, and continuously improve the batch review process as a facilitator for Quality Assurance in product teams
- Identify, develop, and implement key performance metrics associated with the post-manufacture assembly of records, including CMO performance metrics relating to quality and error reduction
- Conduct risk mitigation in the compilation of records and associated review activities, ensuring a compliant culture of quality
- Perform additional quality-related duties as assigned by Director CMC Operations
Whom we are looking for:
- An MSc. in one of the following areas: Biochemistry, Biotechnology, Chemistry, Chemical Engineering or similar
- More than five years of experience in quality assurance in drug development and commercial manufacturing in the biopharmaceutical industry
- Solid GMP-regulated experience working in GMP quality systems and with drug substances and drug products; clinical and commercial experience in a GMP environment preferred
- Experience interacting with the FDA, EMA and other global health authorities
- Excellent verbal and written communication and presentation skills in English, preferably also in Swedish
- Strong analytical and organisational skills, with attention to detail
- Excellent written, verbal, listening and interpersonal communication skills
- Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment
- Ability to take initiative, prioritise and execute tasks with minimal direction or supervision, maintaining a high level of confidentiality, integrity and discretion at all times
The process:
The assignment is expected to start as soon as possible and will go on for 10 months full-time.
Are you available and have the right background? Apply today!
Responsible recruitment consultant is Lena Arrelöv and researcher Hedda Tornert.
