Roche Pharmaceutical Company invites applications from qualified Quality Assurance and Safety Manager to head our Quality and Safety team. The Roche Quality managers aim to ensure that the company’s product or service is fit for purpose, is consistent and meets both external and internal requirements. This includes legal compliance and customer expectations. The Quality assurance manager will work with other staff to establish procedures and quality standards and to monitor these against agreed targets. In this role, you will be accountable for assessment and continuous improvement of quality system processes with adherence to all regulations. Oversees the 2nd and 3rd shift Quality Assurance staff. This role will as well coordinate the activities required to meet these quality standards and is concerned with monitoring and advising on the performance of the quality management system, producing data and reporting on performance, measuring against set standards. Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. We are courageous in both decision and action. And we believe that good business means a better world. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. Send your recent CV and Cover letter for Roche new vacancies in Research and Development, Software and Engineering, Sales and Marketing, IT, Manufacturing, Legal, Finance, HR, Admin, Technology and Quality Management; In every area of Roche, we’re looking for exceptional people to drive our work and company forward. Because it’s not just a job. It’s a responsibility; We are Roche.
Key Duties and Responsibilities:
• Organize to define quality system, guide and supervise the implementation, to ensure company complies with applicable RD Quality Standards and local regulatory requirements.
• Act as Local safety officer, ensure local case management and global product notification implementation fulfils global standard and local regulation
• Report advert events and recall to local authority according to local regulations.
• Devise and establish a company’s quality procedures, standards, specifications and reviews customer requirements to make sure they are met.
• Act as AQH, communicate, train and monitor on RD Divisional Standard’s local implementation.
• Coordinates and supports for External Audit, Internal Audit.
• Monitor and report on local regulation changes and its impact together to company.
• Handle complaint management, training on process, system and global document; classify PRI, AE report according to local regulation.
• Global product notification (QN& SBN) communication, execute, contact local authority.
• Establish and maintain the good relationship with key contact.
• Recommend valuable suggestion to the company.
• Communicate, train and monitor local implementation of applicable Divisional Standard.
• Lead QA team to assure local relabeling, company permit maintains, supply chain, distributor management, promotion materials review, guide on GxP related content in computer system, etc. to comply with RD quality and local regulatory requirements.
• Quality Documents & Records Control and Change Control. Keep records. Have clear filing and maintain of all documents.
• Conduct business in full compliance including but not limited to Roche Secure, Roche Behaviour in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
• Understand and fulfil the responsibility of line manager’s SHE tasks and duties (as defined in SHE handbook).
Minimum Requirements and Skills:
• Bachelor degree or above, subject on Medical/bio-engineering/ clinical Medicine, Microbiology or biochemistry; license pharmacist or laboratory technician or equivalent.
• Proficiency in both spoken and written English.
• Good command of MS office software application.
• Understand medical device regulation.
• Persistence and the ability to influence others.
• Have above 5 years’ experience, especially in QA management, GSP and ISO certification.
• Good numerical skills and an understanding of statistics.
• Planning, organization and technical skills.
• Strong Leadership, decision-making and Problem-solving skills.
• A strategic approach to work with the ability to lead and motivate a team.
• Superior analytical, interpersonal, communication, organizational and leadership skills.
About Roche Pharmaceutical Company
Roche is a multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Roche is the world’s largest biotech company and also the world leader in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. Our products bring significant medical benefits for patients and doctors, efficiency gains for laboratories and health economic benefits for payers. We focused on innovation and on establishing an international presence worldwide. Roche employs more than 80,000 people and is present in more than 150 countries; it’s these people that we value above all else.