QC Technical Specialist

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 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 validation and related testing functions.
• Co-ordinates & plans 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 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

Knowledge & Skills:

• Experienced in protein determination, chromatography and microbiology.
• Experience with variety of analytical softwares 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.
• Internal Auditor Certification desirable but not essential
•  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
• Education allowance
• 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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Location: Grange Castle (Dublin)