Quality Assurance - Compliance Specialist

at  COSMETICA LABORATORIES INC

Cosmetica is recognized for innovation, excellence, and commercialization with award-winning products. From concept to creation, we offer an unparalleled array of services that will inspire, create and deliver every step of the way. We value and recognize talent and want you to help us create beauty in the world! At Cosmetica Laboratories, we are committed to growing our internal employees and developing them to become the best version of themselves.
Compliance Specialist
The Quality Compliance Specialist will have oversight and responsibility in the overall compliance and governance of the quality management systems according to cGMP regulations and ISO22716 standards; including but not limited to, records review, training, conducting regular internal audits, tracking KPIs, C&S validation, monitoring status of environmental monitoring control program, participating in hosting client and regulatory audits, developing and implementing Hygiene program for the facility, while working closely with stakeholders.
This incumbent will act as a liaison between Procurement and Quality, supporting vendor assessment process and will be responsible for establishing Quality Agreements

KEY ACCOUNTABILITIES:

• Oversees all compliance-related activities such as document control, training management, document control, non-conformance management, change control management, and Corrective and Preventative Action (CAPA) modules in QMS platform as well activities required in effective implementation and sustainability of Plant Hygiene program.
• Establish, monitor, and enhance cGMP compliance programs to ensure sustainability of site compliance with the regulations, ISO22716, and other applicable standards.
• Oversees change controls within QMS alongside relevant stakeholders, involving the review of changes and coordinating the completion of necessary steps with subject matter experts (SMEs) to ensure successful implementation.
• Design, implement and administer appropriate quality training programs, including GMP and Compliance training programs in coordination with stakeholders.
• Effectively collaborate with stakeholders to ensure learning objectives, training profile by role, and supporting materials accurately reflect current GMP policies, company processes, and current regulatory standards.
• Participates in quality system audits, internal self-inspection programs, Health Canada, and FDA regulatory audits, external third party, and customer audits; leads and conducts regular internal Quality/GMP audits according to self-Inspection program (SIP) and according to GMP requirement.
• Spearhead and coordinate corrective action plan with departmental SMEs post audit, contributing to the preparation of audit reports, monitoring progress, and conducting follow ups.
• Maintains current knowledge base of regulations, company policies and standards to ensure that the regulatory and quality assurance function and the quality management system remain in compliance with applicable regulatory and industry standards/requirements and current with industry trends and best practices.
• Manages interactions with regulatory agencies, liaison with Health Canada/FDA.
• Work closely with procurement team to provide support in vendor Assessment program through desk audits and assessment of Supplier questionnaire forms. Assist in establishing and updating Quality Agreements with clients and API suppliers, coordinating meetings and negotiations to achieve alignment on requirements.
• Formulates and administers policies and standard operating procedures (SOPs) relating to the Industrial Hygiene function and the quality management system. Responsible for trending site Industrial Hygiene compliance metrics to identify and propose strategic plans to develop corrective actions as required. Oversees all projects related to implementation of Industrial Hygiene and other quality system platforms.
• Performs Microbial risk assessment on any significant change that may impact validation studies.
• Serve as a backup of Compliance coordinator, supporting compliance activities such as delivering GMP trainings, updating and maintaining employees training profiles, releasing approved documents in QMS, assessing Document Change Request (DCR), reviewing drafted document (procedures/ work instructions) by other users for compliance, and other administrative tasks related to Quality Management System.

EDUCATION, EXPERIENCE AND QUALIFICATIONS REQUIRED:

• University degree with preferably Microbiology or Biochemistry background or any related science along with equivalent work experience
• Minimum of 5 years’ progressive experience in a cGMP compliance environment such as Pharmaceutical, Food or Cosmetic industries

SKILLS / KNOWLEDGE:

• Strong knowledge of government regulations; global market requirements / regulations; globally and application of regulations in a pharmaceutical and cosmetics industry
• Self- driven and exceptionally organized, adept at thriving in dynamic work settings
• Proficient in Microsoft Office and various quality management software and tools, with hands-on experience in implementing eQMS (electronic Quality Management system); with cognitive ability to learn new software
• Exceptional interpersonal skills encompassing effective communication, presentation, and facilitation abilities
• Proven track record in conducting training sessions, leading internal audits, and coordinating and hosting regulatory audits
• Highly organized with the ability to work in a fast-paced environment; Result-oriented and self-motivated person
• Highly methodical with a keen eye for detail, coupled with strong problem-solving capabilities
  Cosmetica Laboratories Inc. is an equal opportunity employer and committed to creating and sustaining an inclusive environment in which all individuals are treated with dignity, respect and one which reflects the diversity of the community in which we operate. Accommodations are available for applicants and employees with disabilities throughout the recruitment process. If you require accommodations for interviews or other meetings, please advise when submitting your application

Please refer the Job description for details