QC Specialist - Microbiologist

Hovione

2mo ago

Job
Full-time
Mid & Senior Level
Cork

AI generated summary

You need a Master's in Chemistry or related field, 3-5 years in pharmaceutical QC, hands-on analytical experience, GMP/ICH training, HPLC/GC knowledge, and strong documentation skills.
You will manage quality control activities, execute analytical tasks, propose methodologies, ensure compliance with GMP and regulations, and support team training and problem-solving.

Requirements

- Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar Chemistry, Biochemistry or Health Sciences field
- Typically requires 3-5 years of relevant experience in a pharmaceutical QC laboratory environment (mandatory)
- Hands-on experience in Analytical Chemistry and QC procedures (mandatory)
- Training and experience of GMP and ICH guidelines standards (mandatory)
- Knowledge on HPLC and GC, and familiarity with Empower Software (desirable)
- Strong understanding and knowledge of GMP practices, analytical theory and techniques
- Fluency in English is a requirement
- Computer literate with good working knowledge of the MS Office package
- Good documentation skills and attention to detail

Responsibilities

Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
Rigorously, accurately, efficiently and professionally manage, execute and support all assigned projects in accordance with applicable GMP, quality operational standards / procedures and legal regulations, escalating as appropriate
Propose new methodologies taking into consideration project demands and requirements
Execute project specific analytical tasks and act as a stakeholder liaison
Provide an example of professionalism and support the induction and training of new colleagues within the area
Ensure that all assigned analytical tasks, including (but not limited to) method development, method creation, method transfer, method validation, protocol preparation and report preparation, in any analytical project is well managed and delivered on time, safely, efficiently, reliably and in a cost-effective manner by performing and planning
Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments, initiating the problem-solving escalation process when unable to solve occurrences within the established period
Ensure the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team as appropriate
Reviews work generated by the team as required ensuring all procedures are followed
Creation, investigation and evaluation of CAPAS, incidents and deviations
Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments
Accurately use and maintain all laboratory information systems
To maintain good hygiene and housekeeping within the laboratory
To maintain all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard and in accordance with Hovione internal procedures
Fulfil and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities
Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements
Assist with audits / investigations as required, following the instruction of QC Management
Support the generation / reporting of KPIs for the team, if required
Develop and accumulate strong analytical chemistry expertise, sharing knowledge of new technologies and methodologies within the area
Provide relevant training to other areas in accordance with established training plans
Participate, as required, in the induction and training of new colleagues
Drive high standards in the QC Laboratories
Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others
Interpretation of data and analysis to ensure meeting strict guidelines on documentation and recording data
Work collaboratively in cross-functional teams and understand each department's function and role in delivery of tests and products
Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
Propose improvements to the area as appropriate and solve problems
Make quality and timely decisions within the quality control tasks under her / his responsibility
Gather relevant data to inform the decision makers regarding complex issues
Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
Undertake any additional tasks commensurate with the role as and when required
Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

FAQs

What is the role of a QC Specialist - Microbiologist at Hovione?

The QC Specialist is responsible for defining and implementing quality control techniques, managing and controlling all Quality Control activities, executing project-specific analytical tasks, and ensuring compliance with GMP, regulatory standards, and company procedures.

What qualifications are required for this position?

A Master's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field is required, along with 3-5 years of relevant experience in a pharmaceutical QC laboratory environment, and hands-on experience in Analytical Chemistry and QC procedures.

Is experience with GMP and ICH guidelines required?

Yes, training and experience with GMP and ICH guidelines are mandatory for this position.

What analytical techniques should the candidate be familiar with?

Candidates should have knowledge of techniques such as High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC), and familiarity with Empower Software is desirable.

What languages are required for this job?

Fluency in English is a requirement for this position.

What types of tasks will the QC Specialist be responsible for?

The QC Specialist will be responsible for tasks such as method development, method validation, data interpretation, problem-solving related to analytical tasks, and maintaining laboratory records in compliance with GLP standards.

Will the candidate be required to support new colleagues?

Yes, the candidate is expected to support the induction and training of new colleagues within the QC area.

Are there opportunities for professional development in this role?

Yes, there are opportunities to develop analytical chemistry expertise and share knowledge of new technologies and methodologies within the team.

What is the company's stance on diversity and inclusion?

Hovione values inclusion and diversity, providing a work environment where differences are respected and everyone is treated fairly, regardless of age, gender, religion, disability, sexual orientation, or ethnicity.

Does Hovione accept unsolicited resumes from agencies?

No, Hovione does not accept unsolicited resumes from agencies or search firms for this job posting. Any unsolicited resumes will become the sole property of Hovione.

Hovione

In it for life

Manufacturing & Electronics

Industry

1001-5000

Employees

1959

Founded Year

Mission & Purpose

Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.