Quality Assurance Specialist - Fixed-term contract

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The PositionJOB OBJECTIVE(s): To maintain and continuously improve the afliate quality system in compliance with Roche Pharmaceutical Quality System requirements, local GxP-regulations and applicable ISO-standards whilst ensuring an uninterrupted supply of quality products to patients. Key Responsibilities ●To conduct regular management review of the QMS by presenting and tracking performance against relevant standards ● To implement quality system in line with ISO/relevant standards by reviewing and understanding divisional SOP, analyse their impact in the local environment and effecting relevant aspects as required ● To identify discrepancies and investigate them via the available quality systems in a timely manner ● To identify and manage changes to processes, persons or systems, evaluate its impact and affected parties, implement planned actions and communicate as required ● To implement local CAPA management by identifying the probable root cause, proposing relevant corrective and/or preventative actions, executing the identied action and evaluating the effectiveness as required ● To conduct quality risk assessments using the quality risk assessment tools , identify risk areas, implementing risk mitigation/elimination measures,and monitor changes as required ● To ensure data integrity by creating, maintaining or implementing relevant SOPs ● To initiate or support quality audits by performing self-inspections, external audits. Identify audit queries, draft audit reports, engage with the relevant parties to implement corrective action and follow up on agreed actions ● To initiate annual mock recall and support actual recall process by informing the Health authority, liaising with the distributor(s) to facilitate product recall, contacting customers and reconciling the returned goods as required ● To maintain up to date knowledge of PQS by participating in physical trainings or provided in virtual learning platforms as required ● To perform training of personnel involved in GxP activities ● To maintain systems for reporting product complaints, including monitoring of the generic product complaints mailbox on business days ● To manage all complaints received based on the the applicable SOP ● Release commercial batches to the local market, and where applicable, Investigation Medicinal Products to the local clinical trial sites, according to the local regulations, Marketing Authorizations and Clinical Trial Authorizations ● To ensure all required KPI’s in the product release process are met and feedback is provided as required ● To support the returns process by implementing the relevant SOP, ● Ensure compliance with GDP guidelines and local regulations for the products distributed to the market ● Support batch traceability for all batches received and distributed by the local warehouse ● Coordinate with the supply chain responsible to manage additional controls for cold chain management ● To support the identication and selection process for GxP suppliers ● To create and maintain quality agreement with the GxP supplier ● To assist with oversight of warehouse and distribution business partners by monitoring compliance with the required standards stipulated in the quality agreement ● To ensure implementation of the SOPs, identify areas of concern and address these with the service providers until resolved. ● Perform audits and assessment of contracted third parties ● To liaise with internal and external stakeholders by providing input on quality standards and procedures, liaising with them on procedures and building skills in the quality standards and procedure requirements as required WHO ARE YOU? ● University degree in one of the following or related science disciplines: pharmacy, medicine, pharmaceutical chemistry and technology, or biology ● 3 - 5 years’ experience in pharmaceutical or medical device environment, Regulatory and Quality Assurance Management ● Demonstrate evidence of maintaining and upholding rules and SOP’s Must have knowledge of: ● Current regulatory framework and regulations ● Quality assurance and Quality Management within pharmaceutical environment ● ISO Standards Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.