Quality Assurance/Regulatory Supervisor
Job Type: Full-Time Wage: NEG
Quality Assurance responsibility will be to establish optimal documentation collection, tracking, retrieval and archival to support GMP compliance activities management processes. The associate will also be responsible for maintaining registers and compiling metrics of the quality and the Pharmacovigilance systems. The Quality and Regulatory Supervisor will also support the Quality Manager in releasing of finished products by reviewing and archiving relevant batch record documentation as well as managing retained samples.
Specific Job Duties:
- Perform comprehensive and detailed investigations relating to manufacturing/packaging, complaints, OOS investigations and analytical failures to ensure compliance with GMPs, GLPs and OSG WIs and SOPs
- Create/issue QA protocols for sampling and/or inspections and lead AQL evaluations
- Work collaboratively with site operations in the resolution of GMP deviations
- Liaise with Operations, Validation, QC, Regulatory Affairs, other QA teams, Manufacturers, Suppliers, Customers, to obtain necessary information/documentation required for product review/release/investigations
- Provide clear QA guidance
- Work with various operational departments to negotiate, follow up and facilitate the completion of CAPAs
- Review and approve out-of-specification investigations and provide impact assessments
- Review and release of finished products
- Attend meetings and participate in decision making, issue resolution, coordination of work assignment and work reporting, drive for timely completion of investigations and implementation of CAPAs for self and team
- Review and provide feedback on investigations and procedures for team members
- Review and approve IQ/OQ and Validation protocols
- Participate in internal Quality Assurance audits
- May participate in the quality inspections and audits of outsourced manufacturing facilities and supply chain
- Preparation, compilation, writing and review of international registration dossiers. These include, but not limited to original submission registrations, renewals, notifiable change, supplements, class labeling, annual DIN notifications, variations and written responses to queries
- Perform other duties as assigned
- Ability to efficiently analyze problems, demonstrate informed judgement and make good decisions within appropriate time frames.
- Excellent communication and interpersonal relations skills.
- Knowledge of Quality systems such as recall, internal audit, annual product review.
- Experience in Quality assurance, Regulatory and Quality control within the pharmaceutical field.
- Excellent organizational, multitasking and time management skills.
- Ability to resolve problems and good analytical skills
- Meticulous and detail-oriented
- Strong observational skills
- Ability to work independently and make decisions based on judgment and integrity
- Proficient user of Microsoft Office products
- Ambition, self-motivation, eagerness to learn, positive attitude and a commitment to continuous improvement
- Ability to manage workflow pressures and competing priorities
- Must have a sense of urgency
- Must have a Bachelor of Science
- Previous experience in a pharmaceutical manufacturing environment and/or knowledge of GMP/GLP would be an asset.
OSG offers competitive compensation, a benefit package and opportunities for advancement. If you would like to work for a dynamic, fast-paced, global manufacturer please submit your resume to HR@osg4life.com