Quality Regulatory/Compliance Manager (Project Based)

At Beiersdorf Indonesia, we want to help people feel good about their skin – and our commitment goes far beyond caring for skin. For 140 years, we have developed innovative skin and body care products for well-known brands such as NIVEA and Hansaplast. We act according to our purpose, WE CARE BEYOND SKIN, and take responsibility for our consumers, our employees, the environment and society. Behind every brand, every product and every accomplishment are our more than 20,000 employees. It is for them that we live a culture of inclusion, respect and trust that is strongly aligned with our values – CARE, COURAGE, SIMPLICITY and TRUST. We embrace diversity by valuing the uniqueness of each individual and being committed to equal opportunities for all.

:

• To be involved in tender applications to directing quality aspect, producing responses and documents, to ensure consistency in quality of submissions. Also to develop and maintain management information systems relevant to all tender processes.
• Responsible for developing quality management system and review detail design carried out by engineering consultant.
• Ensure BDF Quality guidelines, GMP and local legal requirement are always implemented during design, construction and commissioning work.

Your Tasks:

• Ensuring delivery of solutions and services meet requirements and that acceptance and handover to business as usual are managed against agreed acceptance criteria and to a defined plan.
• Assist with global coordination of responses to regulatory inquiries and inspections for production scale up & release.
• Provide guidance or specification based on Beiersdorf guideline for GMP for equipment & facility design.
• Working alongside the Project Manager to communicate and manage stakeholder relationships including manage all permit related with project (ex: BPOM approval, IMB, UKL UPL, SLF etc.)
• Develop and maintain various compliance protocol & reporting, validation & qualification (IQ, OQ PQ & HACCP) of plant equipment & facilities.
• Manage large projects to an acceptable level of risk by balancing scope, time, cost and quality to ensure effective delivery of regulatory changes enabling the company to continuously adhere to all regulatory expectations.
• Lead production trial validation until get approval from authorities (Global R&D).
• Participate in the management and maintenance of a strong change control process throughout the duration of Projects & Lead strategic planning sessions and facilitate production of workstream deliverables.
• Coordinate with vendors as appropriate to ensure high quality and timely execution of projects.

Your Profile:

• Previous compliance, Regulatory, business analyst or project management experience preferred
• Willing to work in limited contract for 2 years
• Flexible and dynamic – quickly adapt to changing needs of the business.
• Knowledge and experience of compliance and regulatory environments
• Strong knowledge with EHEDG, cGMP, CPKB & QMS
• Familiar with SAP systems
• Experience in relationship building / management throughout the project life cycle with Compliance partners.
• Previous experience working in a distributed QA environment.
• Pro-active, motivated, and energetic
• Bachelor’s degree in a related field or equivalent experience
• Experience / involving executing build capital projects.
• Minimum of 5 years of related work experience.

Additional Information

We embrace Diversity and Inclusion and are committed to providing equal opportunities to all of our applicants – regardless of race, gender, age, religion and beliefs, sexual orientation and gender identity, disability, cultural, ethnic or national origins. We would therefore kindly ask you to include only information and data in your documents which are relevant for the assessment of your application (e.g. curriculum vitae, salary expectations, relevant references and certificates) and encourage you to upload your CV.