Cache of job #13910746

Job Title

Manager QA Operations (Downstream)

Employer

Careerwise Recruitment

Location

Limerick

Description

MANAGER QA OPERATIONS (DOWNSTREAM) required by CareerWise Recruitment on a permanent basis for our BioTech client in the Mid-West. Candidates coming from a Downstream / Upstream / Pharma operations background will be considered. The MANAGER QA OPERATIONS (DOWNSTREAM) will report to the Associate Director QA and will provide QA oversight to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents. THE ROLE: * Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions: Master records, executed records, failure investigations, Change Controls, SOPs, validation protocols and summary reports and incursions. * Approves various documents relating to area function, including those listed above. * Organizes QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management. * Performs compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions. * Reviews customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality. * Provides advice and direction to other company departments on quality issues. * Participates in regulatory and customer audits. REQUIREMENTS: * BS in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with experience in a pharmaceutical/biologics manufacturing environment desired. * Minimum 5 years experience in pharmaceutical industry with 2 of those years to include leadership and/or supervisory experience. 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

2106 days ago

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