RRxCo is partnered with a UK-based business established in 2010 focusing on antibody, protein and peptide drug conjugate medicines and technology. The bioconjugation team was formed in 2011 and moved into a state-of-the-art facility in 2018. The facility has been built for containment; with the safety of their people and the environment in mind, and bespoke laboratories have been designed specifically to accommodate highly potent bioconjugations.
Antibody Drug Conjugates combine the cell and tissue specificity of monoclonal antibodies with the cell-killing potential of highly potent small molecules and represent one of the fastest-growing sectors in the oncology field.
Summary
The Validation Manager must ensure that validation is carried out compliantly and to time. This person must own and manage the site validation system, including the Site validation master plan and be involved in the validation of equipment and systems.
This involves:
* The writing of SOPs
* Writing or supervising the writing of validation protocols
* Protocol Execution or the support of protocol execution when being done by the responsible department
* Managing and reviewing qualification work completed by vendors and subcontractors
* Writing or supervising the writing of the associated validation reports
The Validation Manager must also be able to write other documentation such as technical reports and risk assessments and assist and document problem solving and process improvements
Deliverables
General:
* The writing of SOPs
* Writing or supervising the writing of validation protocols
* Protocol Execution or the support of protocol execution when being done by the responsible department
* Managing and reviewing qualification work completed by vendors and subcontractors
* Writing or supervising the writing of the associated validation reports
* Write other documentation such as technical reports and risk assessments and assist and document problem solving and process improvements
* Provide compliant validation of facilities, equipment, utilities, products and processes, in line with regulatory requirements to time.
* Write documentation such as validation protocols, reports, procedures, investigations, risk assessments to time and supervise others performing these actions
* Drive and assist in validation activities
* Assist in problem solving/process improvements
HSE:
* Comply with all HSE requirements including safety policies and procedures
Operational:
* Work with QC, New product introduction, Production management, QA and QP (as required) to ensure timely documentation of validation.
* Work within project teams to communicate plans, progress and issues.
* Produce documents such as URS, DQ, FAT, SAT, IQ, OQ and PQ to support equipment qualification, product development and production projects.
* Document any anomalies compliantly and aid resolution of these and other issue
Profile of the individual
* Proven track record in the pharmaceutical industry (or a related industry) – minimum of 4 years
* Minimum 3 years hands on experience in a validation role within either Pharmaceutical or Biopharmaceutical environment, in the qualification of simple and more complex equipment (laboratory equipment and manufacturing equipment e.g. Temperature controlled units, laboratory equipment and mixers, bioreactors)
* Thorough knowledge of cGMP validation requirements
* Experience of equipment qualification (lab and manufacturing)
* Experience using Microsoft Office (Word, Excel, PowerPoint) and formatting skills
* Knowledge of GMP & GLP Systems
* Knowledge of GMP validation requirements (Eudralex vol 4 Annex 15) and Guidance documents (e.g.ISPE)
* Knowledge of Quality systems, Data Integrity, and Quality Risk Management
* Ability to work accurately, with attention to detail in documentation reviews
* Good communication skills with the ability to form strong working relationships with stakeholders at all levels across the organisation
* Approachable and friendly, with the confidence to constructively challenge results and performance when required
Desirable:
* CSV expertise
* Experience in Clean room validation
* Experience in using electronic documentation management systems