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Title: Quality Systems Associate

Reports to: Quality Assurance Manager

Department: Quality Assurance / Quality Control

Supervises: Documentation Control, Specifications & Validation Technician (s)

Organizational Relationships: Contact with all areas of QA/QC, R&D, Purchasing, Operations, Process Engineering, Warehouse, Customers, and other area personnel.

Basic Function:

• Reviews and approves/confirms all new formulas in the Quality Systems
• Co-ordinates process validation and product stability programs and maintain associated reports.
• Conducts Annual Drug Reviews and Device History Reviews.
• Maintains regulatory documents and all documents of external origin.
• Maintains Change Control Notices (CC) and effects changes to product specifications for raw materials, bulks, intermediates and finished goods.
• Participates in internal and external audit process.
• Participates in product recall audits.

Responsibilities :

• Perform process validation and cleaning & sanitization validation under the quality systems to ensure compliance.
• Maintain formal drug stability program by coordinating samples submission, testing, result retrieval and program review
• Maintain files and database of customer-approvals and documents as evidence of authenticity.
• Effect changes to specification sheets as approved through proper change control requests.
• Initiate Change Control Requests for Customer requested changes to raw material, intermediate/bulk, FGs, specifications.
• Maintain copies of approved change controls as applicable to product specification updates/revisions.
• Maintain SOP binders and updates such through approved CCs.
• Communicate new and updated SOPs to all employees at EWL.
• Co-ordinate with HR during employee training and documentation.
• Maintain suppliers and vendors qualification program.
• Participate in internal audit process.
• Participate in product recall audits.
• Perform annual drug and device history reviews.
• Any other special projects and duties at the discretion of the immediate supervisor

Requirements

Qualifications:

• Minimum of 4 years of college
• 3 to 5 years industry or related experience.
• Previous experience in Pharma, Cosmetics, food, medical device, or allied profession
• Good technical writing ability.
• Excellent knowledge of Word, Excel, Access, and other Windows-based programs
• Good record-keeping skills.