JOB Description – QA Manager
- Coordinate and document internal quality assurance processes.
- Review and maintain batch documentation and maintain Quality Systems such as SOPs, GMP training, APR, third party audits, change control, artwork, deviations and incidents.
- Provide support for commercial OTC/Generic business by ensuring timely review of batch documentation and disposition, product availability on timely matter, compliance for OTC product distribution/destruction program, service provider qualification and interface with CFT members as required and ensure quality compliance to agencies such as FDA, DEA and Internal Quality Requirements.
- Manage GMP inspections and audits from both regulatory authorities, FDA, DEA, UL and marketing partners and provide follow-up responses for all aspects of the business
- Review and approve documents as required, including protocols, reports, document changes, etc.
- Provide support for OTC Product’s Stability and Reserve Sample Program along with activities involved in Contract Labs Qualification by conducting Audits.
- Provide cGMP trainings for cross functional departments.
- Ensure compliance to validation process meeting external and internal quality requirements.
- Meet expectations of new and existing retail customer’s quality requirements.
- Knowledge on Process validation, Cleaning validation and Facility Qualifications.
- Ensure timely completion of APQR for all OTC Products as per internal procedures and update annually.
- Identify critical observations out of APQR and provide updates to Senior Management. Comply and adhere to the Internal Code of Business Conduct and Ethics (COBE) and all Company Policies and Procedures.
- Responsible for communicating quality issues to executive management, including resource requirements to maintain compliance.
Deliverables
- Awareness of best practices in quality management in pharma and other relevant industries for potential application at the Medicines Company.
- Assures that SOPs related to QA are updated
- Works closely with supply chain quality assurance to coordinate quality management activities
- Excellent influencing and interpersonal skills, as well as the ability to influence and interact at multiple levels of the organization, manage multiple priorities, and deliver excellent results is required.
- Strong influencing and collaboration skills, and excellent written and verbal communications skills are required.
- Proven experience interfacing with regulatory authorities, notified third party audits and either leading or being in a lead role during regulatory inspections.
- Must have experience or direct knowledge in several quality system elements (e.g. complaints, document change control, standards and systems management, quality directive and procedures, Annual and Product Quality Review APR/PQR, Compliance related field actions, alerts and like events).
If you are interested in this opportunity we’d love to hear from you. Please get in touch by emailing your CV to aurohealth.careers@aurohealth.com