Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
POSITION SUMMARY:
A QC Technical Specialist is required for the QC department for a purification and aseptic manufacturing plant and packaging plant in 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 providing technical expertise and support functions for the 3 teams within Quality Control, Chemistry, Microbiology and Incoming QC. Reporting directly to the Quality Control (QC) Systems Lead, as part of the QC Technical Team, the role will have a focus on method transfers, new product introduction, systems support, equipment validation, continuous improvement and implementing a lean culture.
KEY RESPONSIBILITIES:
* Expert in a wide variety of analytical techniques including but not limited to Protein Determination Assays, Immunoassays, Chromatography assays (GC and HPLC), Microbiological and Aseptic Techniques.
* Familiar with incoming/release testing of raw materials and packaging materials.
* Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
* Responsible for troubleshooting, 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 validation and related testing functions.
* Co-ordinate & plan activities related to the successful method transfers and optimization 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.
* Trending of 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 maximize 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.
KEY COMPETENCIES:
* 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 decisions.
* 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.
Knowledge & Skills:
* Experienced in protein determination, chromatography and microbiology.
* Experience with a variety of analytical software including Empower and Tiamo.
* Strong background in method transfer and qualification.
* Experience in analytical equipment and computerised system qualification.
* Excellent verbal and written communication. Must be able to read, write, and speak English.
* Strong understanding of Data Integrity and ALCOA principles.
* 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.
* Experience of managing project groups and leading high performing teams and delivering results desirable.
* Experience of raw material testing equipment including NIR desirable but not essential.
* Experience with SAP desirable but not essential.
* Knowledge of Computerised System Validation regulatory requirements desirable but not essential.
Qualifications:
* Bachelor’s degree in technical discipline (e.g. biochemistry, chemistry, microbiology) or equivalent.
* Minimum of 5 years’ experience in a pharmaceutical/healthcare Laboratory.
* Preferable 2 Years’ experience in a similar role.
Our Benefits Include:
* Highly competitive salary.
* Group pension scheme - Contribution rates are 5% employer and 5% employee.
* Private Medical Insurance for the employee.
* Ongoing opportunities for career development in a rapidly expanding work environment.
* Succession planning and internal promotions.
* Wellness activities - Social activities eg. Padel, Summer Event.
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you.
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