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Associate Director, Global Quality Compliance - Validation

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Akorn, Inc.
Posted: November 15 2016
Application Deadline: No Deadline
Position: Paid

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Description

Job Description

Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

Job Description

This position will provide technical and strategic stewardship, mentorship, and oversight of the Validation and Qualification Operations at the Akorn India Manufacturing site. The role involves use of risk-based approaches to define and assess validation and qualification processes and controls for existing and new facilities, equipment, processes, and critical systems. Responsibilities will include developing and implementing targeted process improvements, as well as strategic-level transformations to the site’s Validation and Qualification Program. This position will lead and integrate initiatives that drive risk based approaches to validation and qualification, validation maintenance, and validation life cycle management. This position ensures alignment with evolving corporate and global standards, quality system element remediation, regulatory inspection information, external benchmarking and best practices resulting in robust inspection readiness and alignment.

  • Develop strategies and actions to continuously improve data management practices assuring inspection readiness.
  • Assess and enhance site level SOPs and corporate level policy documents
  • Work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, root cause analysis and risk assessment.

Addition responsibilities:

  • Serve as the Corporate SME for Risk Management as well as Process, Equipment, Facility and Utility commissioning, qualification, and validation.
  • In collaboration with the Senior Director participates in strategic initiatives and corporate activities to include quality system re-deployment, site level remediation.
  • Collaborate with senior leadership team in meeting corporate goals.
  • Author pertinent SOP's and validation documentation.
  • Provide leadership in the preparation of Change Controls, investigations, and CAPAs

Qualifications

  • M.S degree (preferred) in Engineering or other relevant Life Science discipline with a minimum of 12+ year pharmaceutical/biotech experience, or a BS with 15+ years of pharmaceutical/biotech experienced based on the required skill set.
  • 75% International Travel Required.
  • Experience in project management.
  • Working Knowledge of applicable cGMP regulations (21CFR 211, EU GMP, PIC/s GMP, USP,EP, ICH)
  • Computer skills with utilization of Microsoft Office (Outlook, Word, and Excel) are required.
  • Effective time management and organizational skills
  • Strong attention to detail and cross functional teams experience
  • Strong leadership skills, ability to drive accountability, compliance and efficiency throughout the department
  • Highly creative, able to conceive and develop ideas to successful laboratory implementation.
  • Skilled at team motivation and people development.
  • Demonstrated excellent written and verbal communication skills.
Company Description
Our Company

Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

EEO Statement

Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

How To Apply

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