- Plan and perform internal & external audits (raw material, printed and non-printed components, contract labs/manufacturers) against GMP regulations, or other appropriate regulations as standards.
- Oversee the Foreign Supplier Verification Program
- Establish audit teams with appropriate skill sets
- Report audit findings
- Evaluate corrective action plans and monitor completion
- Ensure audit schedule adherence
- Issue audit closure letters
- Schedule, host, and respond to regulatory, customer, and certification audits
- Coordinate audit documentation and personnel
- Approve SOPs and other cGMP documentation as needed.
- Master and Production Batch Record retention
- Release bulk and finished product to market
- Pest Control Program
- Environmental Monitoring Program
- Change Control Approval
- Equipment IQ/OQ
- Metrology
- Food Defense Plan and subject matter expert.
- Monitor facility metrics
- Conduct Audits
- Maintain Qualified Supplier list
- Prepare and/or approve Annual Product reviews (APRs)
- Prepare and/or approve Customer, Contractor and Supplier Quality Agreements
- Bachelor's degree in science, compliance, or related required
- Master's degree preferred
- 5+ years of GMP managerial experience within pharmaceutical quality assurance and compliance.
- Minimum 2 years conducting and hosting GMP audits of pharmaceutical and/or supplement manufacturers.
- US FDA and EU EMEA cGMPs for pharmaceutical and supplement manufacturing
- Pharmaceutical Quality Systems
- ICH, USP, and EP Guidance
- Analytical principles and manufacturing processes
- Validation study designs (e.g., method, cleaning, process)
- Data analysis
- Effective written and oral communication skills to all employee levels
- Knowledge of computer program validation principles
- Excellent technical writing skills and attention to detail
- Experience in auditing compliance (e.g. EU, FDA, GMPs)
- Ability to manage multiple tasks and meet deadlines
- Proficient in Microsoft Word, Excel, Power Point, Microsoft Office Outlook
- Required training in SOP, cGMP, and General Safety procedures
- Required to use hands to operate computer controls.
- Specific vision abilities required include close vision, ability to focus.
- Required to be present in the office to collaborate with directors, peers and other departments daily.
- Responsible for adherence to safety policies.
- Flexible schedule to meet business requirements
- Responsible for managing non-union employees
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Senior Manager; QA Compliance - Hauppauge, United States - Contract Pharmacal
Description
Position Summary:
The Sr.
Manager of Quality Assurance Compliance - Audits has primary responsibility for all activities related to cGMP audits including hosting regulatory, customer, certification audits and directing/conducting all 3rd party and internal audits.
In addition, the position is responsible for managing the Document Control team and facility compliance to support audit functions.Responsibilities: Responsibilities include, but are not limited to:
Audit Program:
Document Control:
Facilities:
Supplier/Contractor Qualification:
Education and Experience:
Preferred Certifications:
. Foreign Supplier Verification Program
.Preventative Controls for Human Food
.Preventing Intentional Adulteration of Human Food
.ASQ Certified Quality Auditor (CQA)
Skills, Abilities and Knowledge:
Physical Demands:
Work Environment:
Supervisory Responsibilities:
Salary Range:
$90,000 - $120,000 per year
