Regulatory Affairs Pharmacist
2 days ago
Regulatory Compliance:
- Ensure company products comply with applicable regulatory standards (FDA, IPO, etc.).
- Prepare, review, and submit regulatory filings, such as licenses, and certifications.
- Monitor and keep up to date with changes in regulations, industry standards, and compliance requirements.
- Act as the primary point of contact with regulatory authorities and auditors, managing external inspections and audits.
- Ensure compliance with labeling, packaging, and documentation requirements for all products.
Quality Control:
- Develop and implement quality control protocols and procedures for incoming materials, in-process production, and finished products.
- Perform inspections, testing, and sampling of materials and products to ensure they meet established quality standards.
- Collaborate with production teams to troubleshoot quality issues and implement preventive measures.
- Maintain and calibrate QC equipment and ensure testing environments are in compliance with required standards.
Documentation and Reporting:
- Maintain and organize records of QC inspections, test results, and regulatory submissions.
- Draft, review, and update quality and regulatory documentation, such as Standard Operating Procedures (SOPs), product specifications, and certificates of analysis (CoAs).
- Prepare and present reports on product quality and regulatory compliance to senior management.
Qualifications:
- Bachelor's degree in Pharmacy or any related courses.
- At least 1 year of experience in regulatory affairs, quality assurance, or a related role.
- In-depth knowledge of regulatory requirements for the specific industry (cosmetics, food, etc.).
- Experience with quality systems such as GMP or similar.
- Strong attention to detail and organizational skills.
- Excellent communication and interpersonal skills to collaborate with internal teams and regulatory bodies.
- Ability to work independently and manage multiple priorities.
Job Type: Full-time
Pay: Php25, Php30,000.00 per month
Benefits:
- Employee discount
- On-site parking
Work Location: In person
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