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Job ID: JOB-13561

QC Chemistry Analysts – O3

Location Carlow

Duration 11 Months Contract 

Role Description:

Our Carlow site are excited to offer fantastic QC Analytical opportunities for candidates interested in a new challenge in a cGMP regulatory environment. We have built a new state of the art Quality Operations laboratory and we are looking for QC Analysts who will report directly to the QC Chemistry Manager and who will help us in the start-up of this laboratory.

Core to the role is to perform testing of samples to support the release of our key drug products and as Senior QC Analyst you will mentor and lead a team of analysts and complete analytical method transfers, method validation and testing. You will have 1- 3 years experience in a pharmaceutical laboratory, ideally with experience in HPLC and relevant systems and software. It is preferable that you will have demonstrated experience with lean methodologies in a QC environment.

Our Quality Operations Laboratory team is growing, and we are interested in you! At this time, the team is working a shift pattern and may divert back to day hours in the coming month, so flexibility at this time is an ask!

Current shift requirement – 2 cycle shift

• Morning (7am -3pm Mon-Thu, 7am-2pm Friday)
• Evening (3PM-11PM Mom-Thu, 2pm-9pm Fri).

Role Function

• Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Ability to lead/mentor team of lab analysts
• Act as testing SME within the QC department, leading OOS investigations and supporting troubleshooting activities
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc
• Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same
• Operate as part of the QC team performing the allocated testing and laboratory-based duties
• Will have responsibilities in analytical transfer and validation of methods.
• Perform various analytical techniques including but not limited to HPLC and UPLC, (HIC, IEX, SEC), Capillary Electrophoresis and other compendial test methods in compliance with cGMP requirements
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
• Provide support with audit/inspection requirements to ensure department compliance/readiness

Experience, Knowledge & Skills

• Bachelors degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline
• 1-3 years of experience in a pharmaceutical laboratory
• Good working knowledge of HPLC and UPLC systems and software is desirable
• Good knowledge of cGMP, GLP, Quality Management Systems

Qualifications & Education

• Bachelors degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline
•  

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. 

They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

For further information on this role please contact Maraleeze on 086 4410614 / recruit@hero.ie 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Maraleeze Keane

JOB-13561

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