QC Technical Specialist is required for the QC department of a new purification and aseptic manufacturing plant at Grifols Worldwide Operations (GWWO).
This role offers a chance to work in a state-of-the-art facility, in an innovative Biotechnology company with excellent career development opportunities, and a clear and committed patient focus. The role will be responsible for leading without direct supervision, coordinating and providing technical expertise with a focus on method transfers, continuous improvement and implementing a lean culture. The role may involve travel abroad and carrying out tasks that are not described in this specification but are related to the role.
Reporting directly to the Quality Control (QC) Manager of Grifols Worldwide Operations (GWWO).
· Expert in a wide variety of analytical techniques including but not limited to Protein Determination Assays, Immunoassays, Chromatography assays, Microbiological and Aseptic Techniques.
· Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. Responsible for trouble shooting, problem solving, providing technical guidance and applying expertise and critical thinking to independently resolve technical issues.
·Lead training of staff on technical aspects of job as required.
· Develop, revise and implement procedures that comply with appropriate regulatory requirements.
· Qualification of analytical equipment and computerised systems and related testing functions.
· Co-ordinates & plans activities related to the successful method transfers and optimisation of QC methods into GWWO.
· Compliance with Standard Operating Procedures and Registered specifications.
· Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
· Ensure timely completion of Laboratory Investigation Reports, Out of Specification (OOS) investigations and deviations.
· Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
· Approval of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
· Participate in regulatory agency inspections as required.
· Plan and implement procedures and systems to maximise operating efficiency.
· Manage and contribute to the achievements of department productivity and quality goals.
· Ensure the laboratory is operated in a safe manner.
· Travel where required including foreign travel as part of the role.
· Skilled in the use of problem-solving tools/techniques
· Excellent written and verbal communication skills
· Experience with deviation investigation, risk assessment and CAPA implementation.
· Experience with Change Control process and implementation.
· Experience with analytical equipment qualification.
· Experience in method transfer, validation and verification.
· Knowledge of applicable Regulatory requirements
· Experience with Regulatory inspections and interacting with inspectors
· Ability to handle multiple projects and deadlines, with experience working with cross-functional teams and influencing decision
· Good communication skills and the ability to collaborate at a variety of levels within and outside the organisation
· Ability to work on own initiative without direct supervision
· Ability to work accurately under pressure
· 5 years of experience in a pharmaceutical/healthcare Laboratory.
· Strong background in protein determination, chromatography and microbiology.
· Experience with variety of analytical software's including Empower and Tiamo.
· Strong background in method transfer and qualification.
· Experience in analytical equipment and computerised system qualification.
· Excellent verbal and written communication.
· Fluent in both written and spoken English.
· Must have strong technical writing skills.
· Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
· Strong organizational, analytical and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.
· Bachelor's degree in technical discipline (e.g. biochemistry, chemistry, microbiology) or equivalent.
· Experience of managing project groups and leading high performing teams and delivering results
· Experience with SAP
· Knowledge of Computerised System Validation regulatory requirement
For more information Contact Ann Marie Corcoran.