QA Compliance Lead

• Participating in the development and maintenance of quality systems, processes and procedures to assure product quality and safety.
• assisting the quality assurance site manager in preparation for internal/external audits and implementation of corrective actions to address non-conformities
• supporting risk management process throughout the product life cycle and providing senior mgt with key data from RA to help drive decisions.
• Supporting, development and maintenance of product approval/clearance/licensing documentation and notifications as required by global regulatory agencies
• Assist in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
• communicates and implements a strategy to ensure compliance
• responsible for review of batch records in support of disposition of bulk drug substance
• responsible for review of equipment validation protocols and report
• general compliance quality systems management support for the following areas:
• Raw material and solution release
• Review of raw material specifications and solution docs
• Release of single use disposable product to include label reconciliation
• review of temp. charts and docs or temp related excursions
• review and update label issuance and reconciliation process

General QA documentation support to include the following

• Issuance of batch records and issuance and tracking of log books, lab notebooks and SOP binders
• Scanning and filing of excursion docs and client related batch docs to support batch release
• Develops process improvement plans using a variety of quality and continuous process improvement tools, including but not limited to Six Sigma, Lean Manufacturing, SS, SPC, engineering studies, DOE Gauge R&R, etc.
• BA degree or a min. of 5yrs work exp.
• 3 years exp working in a regulated industry
• Demonstrated understanding or aptitude to understand drug or Pharma QMS requirements and regulatory requirements including but not limited to FDA, CFR 21 210 and 211
• Demonstrated exp. and proficiency with MS Office, word processing, spreadsheet(Excel), presentation and database applications.

Regards,

Monil Patel

Technical Recruiter

Integrated Resources, Inc

(732) 844-8747 Ext.338

monil @irionline.com