Lowongan QA Department Manager, Audit Management, - (R56344) di PT Capsugel Indonesia

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

As a Department Manager, Audit management requires you to provide oversight to day-to-day Quality Assurance activities in accordance with Lonza Corporate requirements, standards and current regulatory requirements, meeting US FDA and European requirements and others as applicable for a large scale, multi-product, GMP biotech contract manufacturing facility. Also, to lead and manage the activities in Audit Management.

Key Responsibilities:

• Provide oversight to day-to-day Quality Assurance activities in accordance with approved Lonza Corporate requirements, standards and current regulatory requirements, meeting US FDA and European requirements and others as applicable for a large scale, multi-product, GMP biotech contract manufacturing facility.

• Mastery and knowledge of processes is recognized by colleagues as a source of expertise.

• Lead activities and strategic planning in Audit Management.

• Ensure quality and delivery of Quality objectives and responsibilities to Lonza and customers.

• Develop and implement continuous improvement actions against the key performance indicators and targets identified for the Singapore site

• Work within the Lonza Global network and establish themselves as an industry expert within both Lonza and outside.

• Direct appropriate follow-up actions on any compliance issues

• Excellent knowledge and adherence to all relevant codes, standards and regulatory requirements

• Lead a team to identify problems, troubleshoot and complete or coordinate corrective action.

• Participate in policy making and Communicate quality operations and compliance perspective effectively to senior management.

• Own and lead special projects, often complex in nature.

• Understand and articulate company business strategy.

• Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates.

• Mentor supervisors and senior specialists, provide input to and involve in their personnel reviews/appraisals.

• Subject Matter Expert for internal, customer or regulatory audits.

• Develop skills as an internal GxP auditor and provide support in regulatory inspections and customer audits as required.

• Designee for Site Quality Head to perform product lot dispositions and assure that product has been manufactured and tested in accordance with cGMP requirements, company SOPs, policies and specifications.

• Assign projects to staff for cost-savings and provide direction to staff and/or lead projects in global harmonization/ efficiency.

• Any other tasks as and when assigned by Site Quality Head

Key Requirements:

• Degree in Science or Engineering in Chemistry, Microbiology or Engineering or related field with 10+ years of experience in Pharmaceutical Manufacturing

• Proficiency in adhering to regulatory requirements and local Codes & Standards, such as FDA, EMEA, and ICHQ7.

• Extensive understanding and practical experience with the validation program within a GMP facility.

• Demonstrated leadership abilities and exceptional interpersonal skills.

• Effective communication skills, both verbally and in writing and possesses analytical thinking.

• Demonstrates qualities of sound decision-making and able to clearly define specific goals, develop action plans, and prioritize tasks accordingly.

• Thorough and systematic approach to tasks and collaborative team player with a strong emphasis on safety, quality, and meeting deadlines.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.