Change Control Administrator

  • Kota Batam
  • Id01 Pt. Ciba Vision Batam Company
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.As a Control Change Admin supporting the Quality Team, you will be trusted to work at the Batam Plant. In this role, a typical day will include:To liaise with relevant departments with regards to ensuring the required changes are carried out in a timely manner.Assist in the review and update of documents in accordance with QMS Requirements.Assist in the introduction of new software where required.Ensure under GDP, all data is effectively controlled, securely managed and stored as required within internal databases.Assist in the provision of reports on the status of the Change Control procedures for inclusion in the monthly Board Report and annual Management Review.Assist during Internal Audit and External Audits by Notified Bodies and Regulatory Authorities where required.WHAT YOU’LL BRING TO ALCON: Bachelor’s Degree in a technical or scientific discipline or equivalentMinimum 2 years experience, preferred in Pharmaceutical/Medical Device IndustryProficient knowledge of cGMP regulations and guidelines including but not limited to medical device technology, ISO 13485, FDA requirements, European DirectivesProficient to communicate in English for both verbal and written.Proficient in technical report writing skills in EnglishKnowledge in Project Management, abilities to lead and manage several projects, meeting deadlines and use critical thinking skills to problem solve effectively, will be an advantage.Excellent verbal and written communication skills to all levels of the organization. Technical writing required.Strong experience as an individual contributor working in cross-functional teams. Ability to influence, negotiate, manage conflict and collaborate.Must demonstrate a “can-do” attitude. Proficient in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, SAP, preferred.