Cache of job #13941866

Job Title

Senior QC Specialist (5 Yrs Exp.)

Employer

Careerwise Recruitment

Location

Carlow

Description

SENIOR QC SPECIALISTS required by CareerWise Recruitmemt for our multinational Biologics client in South Leinster. The SENIOR QC SPECIALISTS will have at least 5 years experience in a pharmaceutical laboratory, ideally with experience in HPLC systems and software. Core to the role will be analytical transfer and method validation to support a number of analytical techniques to support key drug products. THE ROLE: * Act as a Laboratory subject matter expert for testing including but not limited to analytical activities during method transfer and on product release. * Develop, implement and maintain procedures that comply with appropriate regulatory requirements. * Leads method transfers and provides technical expertise, trouble-shooting, training and support to laboratory analysts. * Ensures Quality Control readiness to support all scheduled activities, consistent with requirements to ensure compliance, safety and reliable supply to our customers. * Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of chemical analysis. * Participate in the timely generation of trend data, investigations, non-conformances, validation protocols, reports in support of method validation/verifications and equipment Qualifications. * Leads analytical investigations with a view to providing insight as to potential root causes through problem solving methods and liases with other departments for insight into the investigation. * Manage and contribute to the achievements of department productivity and quality goals. * Represent the QC Department on site/inter departmental projects with Operations / Technical Engineering / Supply Chain as required. * Represent the QC Department on on above site forums as required. * Drive compliance with MSD Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, including maintenance of accurate records. * 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. * Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility. * Identifies and progresses Continuous improvement projects leading to improved lab processes and an improved more efficient work environment. * Performs activities within the Quality Laboratory in compliance with all site, Corporate Safety and Regulatory policies, procedures and guidelines. REQUIREMENTS: * Bachelors Degree; ideally in chemistry, analytical chemistry or a related Science discipline. * At least 5 years of experience in a pharmaceutical laboratory. * An excellent working knowledge of HPLC systems and software is desirable. * An excellent knowledge of cGMP, GLP, Quality Management Systems. * A background in Analytical Transfers is beneficial but not essential. Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. This job originally appeared on RecruitIreland.com.

Date Added

2016 days ago

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