Regulatory Compliance Specialist/Supervisor Job Description Template
Our company is looking for a Regulatory Compliance Specialist/Supervisor to join our team.
Responsibilities:
- Coordinate the preparation of validation reports;
- Develop subordinates in their role;
- Execute Internal GMP and housekeeping audits;
- Perform other related duties as assigned or required;
- Assist Quality Assurance Manager in leading the ongoing development, implementation and verification of Quality Systems;
- Handle Health Canada regulatory audits and customer quality audits in conjunction with Quality Assurance Manager;
- Ensure the maintenance of facility licenses and cosmetic drug listings on regular basis;
- Follow up on audits observations and implementation of corrective and preventative actions;
- Compile and/or execute IQ/OQ protocols for manufacturing equipment and process validation protocols for drug products;
- Oversee change control system. Initiate, review and/or approve changes.
Requirements:
- Experience with root cause analysis, corrective action plans preferred;
- Extensive working knowledge and experience with a document control system;
- Bachelor Degree of Science preferred in Chemistry or equivalent;
- Computer skills in spreadsheets, word processing and databases desired;
- Proven organizational skills and attention to details;
- At least 3 years of Regulatory Compliance/Technical Writing experience in a regulated industry;
- Thorough knowledge of GMPs/GLPs and regulatory requirements is essential;
- Must be able to work independently and interact effectively with others from a variety of positions and backgrounds;
- Ability to effectively multi-task and deal with changing priorities, problem solving.