QC Technical Specialist in Dublin, Ireland

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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Req ID: 520126

Type: Regular Full-Time

Job Category: