Good Documentation Practices Specialist
3 weeks ago
Who we are:
Cosmetic Solutions is a leader in the development and manufacturing of scientifically proven, innovative personal care products. With a focus on, face, body, hair, OTC, and professional use formulations, we create some of the most cost effective, high quality and powerful products on the market.
Providing world class services to up and coming businesses, large established brands, physicians, estheticians and other skin care professionals; we specialize in research & development, custom formulization, graphic design, manufacturing, packaging and delivery.
Job Title: Good Documentation Practices (GDP) Specialist - Personal Care Manufacturer
Overview:
As a Good Documentation Practices (GDP) Specialist at our personal care manufacturing company, you will be instrumental in maintaining the highest standards of documentation accuracy, compliance, and integrity. Your role will involve developing, implementing, and overseeing GDP procedures across various departments to ensure that all documentation meets regulatory requirements and internal standards. With your keen attention to detail and knowledge of industry regulations, you will help foster a culture of excellence in documentation practices within our organization.
Key Responsibilities:
- Training and Education: Provide comprehensive training and education to employees on GDP principles, regulatory requirements, and best practices for documentation within the personal care industry.
- Documentation Review and Approval: Review and approve documentation, including batch records, formulation documents, standard operating procedures (SOPs), and labeling, ensuring accuracy, completeness, and compliance with regulatory standards. Experience opening Deviations, or Non-Conformances.
- Collaborate with Documentation System Management: Document control, versioning, archiving, and retrieval processes, to ensure efficient and compliant document handling.
- Regulatory Compliance: Stay current with regulatory requirements relevant to the personal care industry (e.g., FDA, EU Cosmetics Regulation, ISO and CFR requirements) and ensure that documentation practices align with these standards.
- Continuous Improvement: Identify opportunities for process improvements in documentation practices and systems to enhance efficiency, accuracy, and compliance while supporting overall business objectives.
- Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, Research and Development (R&D), and Manufacturing, to ensure alignment and consistency in documentation practices across departments.
- Audit Support: Support internal and external audits by providing documentation and information as required and assisting in implementing corrective and preventive actions (CAPAs) related to documentation deficiencies.
- Risk Management: Proactively identify and mitigate risks related to documentation practices that could impact product quality, regulatory compliance, or consumer safety.
Qualifications:
- Bachelor's degree in a relevant field (e.g., Chemistry, Biology, Regulatory Affairs) or minimum of [5 years] of experience in documentation management and compliance within personal care, cosmetics, or related industry.
- Strong attention to detail and analytical skills, with the ability to critically review and analyze complex documentation.
- Excellent communication and interpersonal skills, with the ability to effectively train and collaborate with diverse teams.
- Familiarity with electronic document management systems (eDMS), quality management systems (QMS), and Microsoft suite knowledge preferred.
- Certification in Good Documentation Practices (GDP) or relevant areas is a plus.
Cosmetic Solutions LLC. is committed to equal employment opportunity for all employees and applicants for employment without regard to age, color, creed, disability status, gender, national origin, race, religion, sexual orientation or veteran status, or any other legally protected status.
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