Quality Assurance Engineer

QA EngineerWe are currently recruiting for a QA Engineer at our Dardilly, France.The QA Engineer is needed to manage the subcontracting site of GANA and acts as the representative of the legal manufacturer. The ideal candidate must have expertise in lyophilisation process and 4 years’ experience in the medical device, pharmaceutical or biotechnology industries and/or a physical chemistry quality control department.Hours of work: 35Location: Dardilly, FranceAbout SinclairFounded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide. This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.Our VisionProviding aesthetic excellence globally.Our Mission Driving the advancement of product quality and customer satisfaction, investing in innovation and people.Our ValuesAct with IntegrityBe results drivenEmbrace your winning spiritStay ahead of the gameOne team, one goalKey Responsibilities Activities related to Quality Management systemMaintain a close follow-up on subcontracting activities Manage the subcontracting contract with GANAPerform audit of the contract manufacturing site, log audit NC in the Corporate system and ensure follow up of the CAPA plan in collaboration with GanaReview and approval of the process and product validation protocols and reports (manufacturing process, sterile barrier, stability…)Ensure production nonconformity assessment, log of the NC and CAPA in the Corporate system and ensure follow up of the CAPA plan in collaboration with GanaEnsure change control assessment, log of change controls in the corporate system and ensure follow up of the CC plan in collaboration with GanaActivities related to Regulatory AffairsTechnical support to Sinclair's Regulatory Affairs and Corporate Vigilance department for the maintenance of approvals and registration certificates of Lanluma productsPrepare for and support in regulatory audits and inspectionsConformity verification and approval of EC declarations of conformity and technical documentation relating to Lanluma productsActivities related to Materi vigilanceParticipate in the handling of customer complaints and Materi Vigilance cases in collaboration with the Quality and Corporate Vigilance Sinclair departments and with Gana for investigationsParticipate in the validation of security measures in collaboration with Corporate SinclairReview and approval of Materi Vigilance reports prior to submission to the authoritiesReview and approval of declarations and safety measures submitted to the authorities: Field Safety Notice, Field Safety Corrective Action, recalls/batch withdrawals.Participate in post-trade surveillance activities in collaboration with Corporate Sinclair and ensure that appropriate corrective and preventive actions are implemented Activities related to Risk ManagementReview of the QMS risk management process from GANAParticipate in product risk management activities in collaboration with Corporate SinclairYour Skills & Experience – Do You Have What it Takes?Essential:Expertise in lyophilisation process4/5 years' higher education in a scientific and/or quality control field. 4 years’ experience in the medical device, pharmaceutical or biotechnology industries and/or a physical chemistry quality control department.Fluent English (written and spoken)Good command of IT tools (Word, Excel)Based closed to Lyon or agree to move close to LyonDesirable:At least 1 years’ experience in the field of injectable productsKnowledge of the Medical Device Regulation 2017/745A bit about you – do you fit this description?Role competencies:Knowledge of Lyophilisation Knowledge in Audit processKnowledge in NC/CAPA processKnowledge in Change Control processKnowledge of Medical Devices regulations (MDR 2017/745)knowledge of pharmaceutical standardsGeneral competencies:TeamworkTaking the initiativeThe search for continuous improvementWhat We OfferWe have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.This is an exciting opportunity to join a successful company, with big ambitions for the future.If this sounds like you and you meet the requirements, please apply, we would love to hear from you.Please note if we receive a high volume of applications, we may close the role before the closing date noted. By making this application you give consent for personal information to be used in automated decision making processes relating to key job requirements which are stated in this ad.If you have any questions, please email [email protected] does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void.