QUALITY ASSURANCE DIRECTOR - PHARMACEUTICAL

Company: Apothecus Pharmaceutical Corp.
Location: Hicksville
Posted on: June 18, 2022

Job Description:

Job Description Job Description:
Pharmaceutical Quality Assurance Director
OTC Pharmaceutical Company is looking for an experienced Quality Assurance Director
**Must have 5 years current pharmaceutical experience**
**BS Degree required
**Applicant must live on Long Island, NY, or be willing to relocate
Working Hours: 7:00a - 3:30p

Job Requirements:
- Experienced in ISO 13485:2016 Quality Management System (3 years)
- Experienced in SOPs, Reports and Document Control (5 years)
- Experienced in Complaint Handling, CAPA, NCMR (3-5 years)
- Coordinating outside contract laboratories as well as ISO certifications and reassessments.
Must be familiar with: cGMPs, Part 11 compliance, CAPAs, Agency Audits, Internal / external cGMPs, GLP, CFR,
BS Degree required

Job Summary:
- Perform and coordinates the QA department and duties within, ensuring, quality policy and regulatory obligations, are implemented and followed company-wide.
- Review SOPs, STPs and revise accordingly
- Maintain all Quality Assurance master files
- Review and update Quality manual accordingly
- Prepare and carry out validation activities as required
- Perform internal as well as vendor audits.
- Documenting and reviewing quality requirements and agreements of raw materials with suppliers
- Ensuring that manufacturing processes comply with all regulatory standards for OTC and Medical Devices.
- Documenting and determining training needs
- Recording, analyzing, distributing and archiving statistical information
Health Canada, MDSAP program knowledge a plus.
Regulatory experience is a must.

Job Type: Full-time
Salary: Commensurate with Experience
Must be detail oriented.
Great working environment, benefits, excellent opportunity for the right person

Company Description Small OTC drug manufacturer located on Long Island

Keywords: Apothecus Pharmaceutical Corp., Hicksville , QUALITY ASSURANCE DIRECTOR - PHARMACEUTICAL, Executive , Hicksville, New York