QA Sterility Assurance Manager

<p></p><p><span>As our QA Sterility Assurance Manager you will be the primary contact for sterility assurance, aseptic and bioburden controlled processes and environmental monitoring.</span></p><p><span> </span></p><p><b><span>Key Responsibilities:</span></b></p><ul><li><p><span>Lead the Sterility Assurance team of 9, manage their work performance, define workload priorities, organize and control their activities</span></p></li><li><p><span>Be the Single Point of Contact (SPOC) for any topic related to Sterility Assurance and Environmental Monitoring</span></p></li><li><p><span>Escalate appropriately to site leadership team and Global Quality Assurance issues/risks associated with Sterility and Environmental Monitoring</span></p></li><li><p><span>Maintain and ensure aseptic procedures are in place and in use</span></p></li><li><p><span>Support investigations where aseptic assurance is at risk</span></p></li><li><p><span>Oversight of microbial control strategy</span></p></li><li><p><span>Establish and monitor Sterility Assurance and EM Key Performance Indicators</span></p></li><li><p><span>Perform internal audits against cGMP rules, company policies and procedures, and the authority regulations concerning Sterility Assurance topics.</span></p></li><li><p><span>Review and approve documents connected with Sterility Assurance topics</span></p></li></ul><p><span> </span></p><p><b><span>Basic Qualifications &amp; Skills:</span></b></p><p><b><span> </span></b></p><ul><li><p><span>University degree in </span><span>pharmacy, microbiology, biology, chemistry, engineering or similar scientific field</span></p></li><li><p><span>Minimum 5 years experience in Pharmaceutical industry with experience in aseptic production or sterile processes</span></p></li><li><p><span>Experience with environmental monitoring, bioburden control and hygiene programs</span></p></li><li><p><span>Strong English communication skills and proficiency in Hungarian</span></p></li><li><p><span>Experience in deviation, investigation, CAPA and change control processes</span></p></li></ul><p><span> </span></p><p><span> </span></p><p><b><span>Preferred Qualifications &amp; Skills:</span></b></p><ul><li><p><span>People management experience and a coaching leadership style</span></p></li><li><p><span>Experience with electronic quality systems or digital tools for quality records</span></p></li><li><p><span>Knowledge of data integrity principles and their application in quality systems</span></p></li><li><p><span>Experience conducting internal audits and preparing for regulatory inspections</span></p></li><li><p><span>Strong problem-solving and risk-based decision-making skills</span></p></li></ul><p><span> </span></p><p><b><span>What we offer:</span></b></p><ul><li><p><span>Hybrid working (2 days in HO per week) with flexible working hours</span></p></li><li><p><span>Permanent contract</span></p></li><li><p><span>Annual bonus and annual salary review</span></p></li><li><p><span>Cafeteria (flexible benefits)</span></p></li><li><p><span>Commuting support (company shuttle buses from Budapest and surrounding towns of Gödöllő, or fuel support if using your own car)</span></p></li><li><p><span>Group life and accident insurance package</span></p></li><li><p><span>Voluntary pension fund contribution</span></p></li><li><p><span>Paid parental and caregiver leave</span></p></li><li><p><span>Modern and clean working environment with an innovative culture</span></p></li></ul><p><span> </span></p><p><span>For further information watch our video summarizing our benefits: <a href="https://www.youtube.com/watch?v&#61;JQHAz40W0Bc" target="_blank">GSK Gödöllő juttatások (youtube.com)</a><br /><br /><b>#LI-Hybrid</b></span></p><p></p><p></p><p><b>Why GSK?</b></p><p><b>Uniting science, technology and talent to get ahead of disease together.</b></p><p></p><p>GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.</p><p></p><p>People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.</p><p></p><p>Should you require any specific adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on <a target="_blank" href="mailto:hu-inclusion.recruitment&#64;gsk.com"><span style="color:#0000ff"><u>hu-inclusion.recruitment&#64;gsk.com</u></span></a>.</p><p></p><p>Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels’.</p><p></p><p>GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.</p><p></p><p><b>Important notice to Employment businesses/ Agencies</b></p><p>GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK&#39;s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.</p><p></p><p>Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at <a target="_blank" href="https://openpaymentsdata.cms.gov/"><span style="color:#0000ff"><u>https://openpaymentsdata.cms.gov/ </u></span></a></p>