Similar posts
DSP Manufacturing Compliance Team Lead (QA)
This vacancy has now expired. Please see similar roles below...
A speciality biopharmaceutical company is currently seeking a DSP Manufacturing Compliance Team Lead (QA) to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.
Job Responsibilities:
- Coordinate with Quality Affairs to ensure documentation readiness that will be used throughout the manufacturing facility during batches, including batch records and logbooks, etc.
- Assist in the creation and review of important quality related biomanufacturing documents together with MSAT:
- Process Flow Diagrams & Bill of Materials
- Batch Production Records & Analytical Control Plan
- Standard Operating Procedures
- Analytical Procedures
- Material Specifications
- Product Specifications
- Provide technical oversight during biomanufacturing runs, including troubleshooting and review and approval of quality documents such as planned changes, deviations, and excursions.
- Develop and maintain metrics to track batch record turnaround time, errors, and document related deviations.
- Track all quality records (Deviations, Change Controls, CAPA etc.) to maintain compliance.
- Ensure all Manufacturing Documents are fully reviewed before submission to the Quality Assurance group.
- Contribute to post-run debriefs to prepare for next run(s).
- Provide assistance with CMC compilation for regulatory submissions.
- Assist in the development of customized manufacturing training programs geared towards complex unit operations through combination of classroom and hands on practice.
- Collaborate with the MSAT team regarding relevant documentation (PPQ, CPV, and Technical Summary Reports); provide quality oversight, ensuring compliance to regulatory requirements.
- Ensure that the DSP suite and equipment is maintained in a state of Inspection readiness at all times.
- Collaborate with MSAT and contribute towards Technology Transfer of processes to manufacturing scale.
- Contribute as required to successful commercial Pre-Approval Inspections (PAIs), regular Audits, and any other interactions with regulatory agencies.
- Adhere to the company etiquette in all matters of behaviour and manners.
Skills and Requirements:
- Master's in biotechnology, chemistry, bio/chemical engineering, or comparable.
- Knowledge of downstream purification activities.
- Knowledge of regulatory guidelines for biomanufacturing (FDA, ICH, PIC/s) and implementation.
- Minimum 5 years in compliance role for biomanufacturing, desired.
- Proven experience of/ability to lead and manage people and their activities.
- Proven process and equipment validation activities.
- Experience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.
- Expertise working with up-to-date cGMP compliance and associated documentation.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-OB1
#Compliance/Quality
Related jobs
US$180000 - US$210000 per annum + Highly Competitive Salary
Boston, USA
Proclinical is actively seeking a Director of Statistical Programming for a global biotechnology company. This is a permanent role with the opportunity to work remotely.
Highly Competitive
Brussels, Belgium
Proclinical is seeking a Professional Services Resource Manager. This role is pivotal in allocating resources to client projects.
Highly Competitive
Brussels, België
Proclinical are representing a medium sized, global biotech who are expanding rapidly due the significant products that are coming through in our clients pipeline.
Up to US$0.00 per annum + Highly Competitive Salary
Princeton, USA
Proclinical is seeking a talented and motivated Director of CMC for a leading biotechnology company located in Princeton, NJ.
Highly Competitive
Brussels, België
Proclinical has been retained by a cutting edge, biopharmaceutical company to appoint a Global Head of Quality for their commercial manufacturing sites.
Highly Competitive
Valais, Switzerland
Proclinical is seeking an Administrative Assistant to work a 12 month contract.
Highly Competitive Salary
Miami, USA
Proclinical Staffing is seeking an Associate Director, Access & Reimbursement - Oncology to join a global pharmaceutical organization.
Up to US$20 per hour + Highly Competitive Salary
Social Circle, USA
Proclinical Staffing is seeking a Warehouse Clerk to join a global pharmaceutical organization.
Highly Competitive
Leiden, Nederland
Proclinical is seeking a Senior Clinical Scientist to join our team. This role is integral to our development organization as we prepare to start clinical development of our Axiomer pipeline.
Highly Competitive Salary
Middletown, USA
Proclinical Staffing is seeking an Operations Manager, Chemical Manufacturing to join a leading healthcare organization.