Location: Buena, NJ
To provide a safe and healthy work environment for all of our employees and contractors, Teligent has mandated that all employees be fully vaccinated for COVID-19. This means that all new hires will be required to be fully vaccinated prior to their start date. We are taking this proactive step as our community continues to be negatively impacted by the pandemic and the surging Delta variant. Should you require a religious or medical accommodation, please inquire about necessary steps to secure such accommodations.
Conducts and coordinates audits of all manufacturing processes and quality systems to both internal plant and external suppliers to ensure compliance to the guidelines, requirements and regulations of FDA, USP, ICH, Health Canada and any other regulatory agency as needed. Identifies compliance issues and deficiencies and participate in the implementation of corrective actions. Prepares audit reports based on the audit results. Provides documentation requirements and preparation guidance. Develops annual audit schedules. Ability to travel, when necessary
Reporting Relationships: 0-3
- Perform audits of all cGMP department to ensure adherence to the guidelines, requirements and regulations of FDA, USP, ICH, Health Canada and any other regulatory agency as defined.
- Perform audits of suppliers, outside testing laboratories, off-site storage facilities, distribution centers, etc. to ensure adherence to the guidelines, requirements and regulations of FDA, USP, ICH, Health Canada and any other regulatory agency as defined.
- Generate agendas, reports and follow-up documentation as part of the audit process.
- Scheduling, preparation, conduct, documentation and follow-up of assigned GxP audits.
- Initial assessment of audit deficiencies, corrective and preventive actions, and overall vendor/site compliance status based on regulatory GMP requirements and specific Teva requirements
- Communication to stakeholders on potential risk and product impact from observations and GMP deficiencies found during audits
- Provide support to site with supplier qualification issues and supplier risk assessment based on audit result when required/requested
- Support notification to management process in case of critical audit findings.
- Regular participation in GMP trainings (internal/external)
- Develop annual audit schedules for both internal and external audits.
- Engage third party auditors for assistance with audits, as necessary.
- BS degree in a science related field and a minimum of 7 years of related experience.
- ASQ Certified Quality Auditor (CQA)
- Knowledge of cGMP requirements, FDA guidance, Part 11 requirements, ICH guidance
- Quality Inspection strategies
- Compliance Monitoring
- Use of Microsoft Office suite
- Excellent organizational skills.
- Demonstrated ability to work on multiple projects and meet timelines. Detail oriented
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities in a fast-paced laboratory setting.
- Strong interpersonal skills.
- Good written and oral communication skills.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes and controlled area gowning.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.