SOF) Experience in hosting GCP Inspections Experience in IT Systems validation desirable Experience in implementation of general data protection regulations desirable Operational knowledge of GMP, knowledge of GLP and GCLP desirable Northreach is an equal-opportunity employer and we do not discriminate against any employee or applicant for employment based more »
level Project Engineer/Project Manager with experience in managing cross functional teams, delivering complex Manufacturing Facility and processing projects, in a highly automated GMP production environment Demonstrated capacity to effectively manage and execute projects from initiation to completion Equipment & Utility experience Understands project management process; programming, scope development, design more »
Aylesbury, Buckinghamshire, South East, United Kingdom Hybrid / WFH Options
Medik8
to respond to change environments and high growth, high pressure environments. Experience in managing stakeholders. Ability to track and report issues. Experience & understanding of GMP, FDA & TGA Quality requirements. Culture & Benefits We are fuelled by our commitment to sustainability, quality, efficiency, and an unwavering passion for our customers. Championing solutions more »
and validation of analytical test methods in accordance with regulatory guidelines. Support, release and stability testing performed in-house and at CROs and direct GMP investigations. Develop strategies for evaluating and implementing new technologies within Analytical Development. Support process development, setting of specifications and regulatory filings and responses. Participate in … a relevant biological science. Post-graduate degree in biochemistry or related science is preferred. Experience in a cGMP Quality environment. Experience working in a GMP testing environment with an understanding of regulatory requirements and trends related to analytics and product development. Thorough understanding of current regulatory requirements and practical experience more »
disposition. The QA officer will ensure assigned tasks are performed in a timely manner to meet batch disposition, supply chain and all associated international GMP/GDP requirements. Key Responsibilities will include: To compile & review batch document sets for completeness & compliance to EU GMP, Pfizer internal requirements and regulatory dossier … s degree in a related scientific discipline with relevant experience (Preferably Biology/Chemistry/Pharmacy/Life Sciences) 2-3 years in a GMP environment Basic experience in pharmaceutical manufacturing, distribution, and control measures Basic experience in Quality administered systems. Previous use of TrackWise® QMS beneficial. Experience in operating more »
also oversee the work of junior QC staff, assist in managing the QC laboratory, and participate in assay transfer activities. This role requires maintaining GMP compliance in the QC laboratory. Key Responsibilities Establish, revise, and maintain procedures for QC testing. Maintain QC systems related to in-process, final drug product … and review of reports. Requirements A BA or BS in Chemistry/Biochemistry/Microbiology or other related science. Experience in a GLP/GMP environment. Computer literacy (including MS Word and Excel). Ability to work well with others. Effective communication skills. Good organizational skills. If you are having more »
and collaboration with Operations and Quality teams. Major Responsibilities Under the QC Manager's direction, the Incoming QC Team Leader will: Ensure GDP/GMP compliance within Incoming Inspection and Quarantine areas through inspection of incoming goods against specifications. Create and maintain incoming inspection procedures and work instructions. Manage QC … external audits (e.g., BSI, FDA). Support and complete other tasks set by the QC Manager. Skills and Experience Working knowledge of GDP/GMP requirements. Ability to create and write Standard Operating Procedures and Work Instructions/Specifications. Understanding of inspection criteria and the use of drawings/specifications. … area for medical devices. Knowledge of SAP (desirable). Knowledge of Master Control (desirable). Strong written and oral communication skills. Good understanding of GMP compliance requirements in Quality Control. Attention to detail. Promotes a collaborative working environment. Understanding of using basic measurement tools (e.g., calipers/jigs and gauges more »
