Deskripsi Pekerjaan
Aromate Philippines Co. Inc is seeking a detail-oriented and highly motivated Regulatory Compliance Pharmacist to join our manufacturing facility in Santo Tomas, Batangas. In this critical role, you will be the backbone of our quality assurance and regulatory affairs department, ensuring that every product leaving our plant meets the highest standards of safety, efficacy, and compliance with Philippine FDA regulations and Good Manufacturing Practices (GMP).
As our Regulatory Compliance Pharmacist, you will bridge the gap between production and regulatory mandates. You will be responsible for navigating the complexities of product licensing, maintaining rigorous documentation, and fostering a culture of compliance across the manufacturing floor. If you are a licensed professional with a passion for quality systems and a desire to contribute to a growing manufacturing organization, we want to hear from you.
Tanggung Jawab
- Oversee and ensure total compliance with FDA guidelines and Good Manufacturing Practices (GMP) within the production facility.
- Manage the preparation, submission, and follow-up of regulatory applications, renewals, and variations for product licensing.
- Conduct regular internal audits and process reviews to identify potential compliance gaps and implement corrective actions.
- Collaborate with production and quality control teams to ensure batch records and standard operating procedures (SOPs) are strictly followed.
- Maintain and update comprehensive regulatory documentation and filing systems.
- Act as the primary point of contact during external regulatory inspections and audits.
- Provide technical guidance on labeling requirements, marketing materials, and product formulation to ensure regulatory alignment.
Kualifikasi
- Must be a Licensed Pharmacist in the Philippines.
- Minimum of 1-3 years of experience in regulatory affairs or quality assurance within a manufacturing setting.
- Strong working knowledge of Philippine FDA regulations and international GMP standards.
- Excellent technical writing skills with the ability to document complex processes clearly.
- Strong analytical mindset with a keen eye for detail and risk assessment.
- Ability to work effectively in a cross-functional team environment.
- Proficiency in Microsoft Office Suite and quality management software.