Location: Franklin, KY

Job Type: Full-time

Company Overview

PuraCap Pharmaceutical LLC, headquartered in NJ, is a global fully integrated pharmaceutical company with expertise in product development, manufacturing, and bringing affordable, world-class quality products to their customers. The PuraCap corporate structure supports a three-pronged approach for global growth with dedicated companies in the areas of prescription brands (PuraCap Pharmaceutical) as well as prescription generics and OTC and private label brands (PuraCap International LLC). PuraCap continues to innovate using soft gel expertise developing other soft gel and oral solid dosage options.

With recent acquisitions, PuraCap is growing and in need of passionate, knowledgeable, and result oriented people interested in achieving personal success and driving company success.

Puracap Laboratories in Franklin, KY is looking for an experienced QA head to manage its packaging, warehouse and distribution center.

• Position requires a deep understanding of the industry, ideally possessing ten (10) years of first-hand experience in the pharmaceutical, solid oral dosage processing and packaging, clinical trial material and manufacturing segment.
• The QA Associate Director will develop, establish and maintain quality systems programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standard and FDA guidelines. The position holder will provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.

Here are the main responsibilities related to the AssociateDirector –Quality Assurance position:

• Manage all aspects of plant Quality Systems including investigations, validation, CAPA, Change Control, documentation, batch review and disposition, in-process Quality Assurance, complaint management.
• Chief compliance officer of the installation and the good manufacturing practice of the facility (GMP – FDA).
• Ensure quality Operation:
• Master Batch Record ;
• Clinical trial packaging protocols;
• Master label copy (artwork);
• Randomization list;
• Material/products specification documents;
• Executed Batch record ;
• Stability study protocols;
• Certificate of Analysis / Certificate of Manufacture or Compliance;
• Approving or rejecting material and product;
• Product Development reports;
• Calibration and preventive maintenance records.
• Hosting of Regulatory Agency inspections, internal and customer audits. Including the preparation of a response for any deficiencies noted and action plan follow up;
• Responsible of auditing and approval of vendors ;
• Ensure the appropriate process, equipment and facility validations meet expectations for validations, process capability, corrective actions and general compliance or both for applicable regulatory agencies;
• Coordinate and maintain site licensing (FDA, New York State, DEA, other as applicable);
• Minimize the management costs of the quality and decrease the non-quality costs;
• Contribute to the improvement of the systems quality while allowing the increase of the profitability of the company;
• Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant.
• Establish and monitor quality level metrics and develop improvement plans.
• Ensure team compliance with all policies, procedures and site/company regulations.
• Investigate and adjust customer complaints regarding quality.

Qualifications :

• Bachelor or Master’s Degree in Sciences or related field with ten (10) or more years of related work experience in pharmaceutical company;
• Strong working knowledge of cGMP and FDA requirements and guidance documents;
• Thoroughness, attention to quality, sense of observation;
• Excellent and proven decision making, problem solving and analytical skills;
• Action oriented/drives for results;
• Leadership, autonomy, initiative, good communication, management, human relations, planning, time and priority management skills;
• Experience in a manufacturing environment, pharmaceutical production, cosmetic or food field, or ISO environment;

To learn more about PuraCap Pharmaceutical, visit http://puracap.com/

To apply for this position, email your resume and a cover letter to humanresources@PuraCap.com

Not only is PuraCap an internationally inclusive company, but we embrace and encourage diversity. PuraCap is proud to be an equal opportunity workplace and is an affirmative action employer.