Quality and Regulatory Compliance Manager Quality Assurance & Control (Science & Technology)New Image International is a pioneer in health and nutritional products. An award-winning business created over 39 years ago in New Zealand. With offices across the Asia Pacific region and growing in Africa and Europe, New Image International has helped people across the world master the art of living well with Nature's ultimate gift of Colostrum.New Image international is looking to establish a new manufacturing operation and we are looking for someone who can assist with this project. The role will be responsible for supervising quality assurance tasks and formulating GMP regulations for the manufacturing facility.Job Responsibilities:Conduct quality assurance procedures to ensure adherence to regulatory guidelines and company protocols.Supervise the establishment of a pharmaceutical manufacturing facility to meet GMP standards of New Zealand and export destinations.Manage the operation of pharmaceutical equipment and maintaining records.Review and approve batch records, Standard Operating Procedures (SOPs), and related documentation.Implement and uphold quality management systems.Assist in internal, regulatory inspections, and customer audits to ensure compliance with current Good Manufacturing Practice (cGMP) and other regulatory prerequisites.Ensure alignment of all Pharmaceutical Quality Systems (PQS) functions with GMP criteria.Establish strong relationships with government officials in Thailand, Vietnam, Malaysia, the Philippines, Indonesia, Cambodia, and other relevant countries.Skills and Experience required:Hold a Doctor of Pharmacy degree to facilitate a comprehensive understanding of ASEAN regulatory requirements.Possess an in-depth knowledge of pharmaceutical quality, safety, and efficacy of drug products and substances.Be familiar with ISO Standards Requirements, Good Documentation Practice, and Good Manufacturing Practice, particularly PIC/s GMP for Medicine in the ASEAN market.A minimum of three years of experience in Quality Assurance within the pharmaceutical sector.Demonstrate attention to detail and analytical capabilities.Proficient in drafting and reviewing SOPs, batch documents, and forms.Proficient in Thai language (reading, writing, and speaking) to communicate effectively with Thai personnel.The role is based in Mangere Bridge, Auckland and the salary band is $65000 to $75000 for a 40 hour week. This will be prorated to $48750 to $56250 as this position is part time, 30 hours per week.If you have the skills and experience required, please apply now.Report this job advert Don't provide your bank or credit card details when applying for jobs.#J-18808-Ljbffr
