- Responsible to manage the Internal / External Audits and host Clients Audits and Regulatory Inspections. Maintain communication with multiple departments to providing support or direction for CAPA completions as part of observations. Also maintain constant communication with multiple clients to provide regulatory requirements Requests.
Reports To: Compliance Supervisor
Key Job Challenges:
- The incumbent is faced with the challenge of hosting Regulatory or Client Audits.
- The incumbent is faced with communicating with multiple departments to providing support or direction for CAPA completions as part of observations.
- The incumbent is faced with the constant communication with multiple clients to provide regulatory requirements Requests.
- The incumbent is faced to challenge all audit responses and prepare the final audit response.
- Provide support for the Controlled substances regulations, licenses and inventories.
- Manage/host DEA/Dept of Health audits, communications and visit.
- Approve site SOP’s
- APR origination or revision
- Support Complaints area
- Revision of training completion on documents
Example of Job Challenges:
- Dealing with multiple projects where there is potential conflict.
- Dealing with multiple requests within and outside of department.
- Hosting Regulatory or Client Audits.
- Conduct internal audits
- Review observations responses.
- Originate or approve APR.
- Review Quality Agreements prepared by compliance specialists.
- Review and approve and propose revisions to QA procedures and SOPs for better compliance and efficiency in meeting clients’ demands.
- Provides quality status updates for client activities and products.
- The incumbent has the authority to prepare and/or approve CAPAs, and prepare GMP certifications and regulatory requirements.
- Perform Internal / External Audits.
- Received and Host Client Audits and Regulatory Inspections.
- Communicate with FDA for licensing and submission, inspection and sampling purposes.
- The incumbent(s) have QA approval authority for protocols and reports
- The incumbent(s) have acceptance authority for change controls.
- The incumbent(s) have QA approval authority to receive federal agency.
- The incumbent(s) have QA approval authority prepare plant certification.
- Assistance is available from the QA Lead, the Manager of Quality Systems & Compliance, Site Director, Production Management, Technical Operations, Engineering, and Human Resources.
A. Must haves:
- Bachelor Science in Chemistry, or related field, or equivalent experience.
- Minimum 5 yrs experience in a Pharmaceutical Industry.
- Solid knowledge of GMPs/Good Laboratory Practices (GLPs)
- Excellent organizational and leadership skills.
- Solid computer experience including lab software, Microsoft Word and Excel.
- Excellent oral and written communication skills.
- Proficiency in English
Technical/Professional Know How:
- Results Oriented
- Problem Solving/ Decision Making
- Client Service
- Communication Skills