Sr. QA Validation Associate

ABOUT THE JOB:

 - Perform validation protocol reviews of the following types of Validation:

Equipment, Process, Packaging, QC Lab, Cleaning, and Utilities.

 

- Ensure compliance to FDA, ICH guidelines, and internal procedures.

 

- Perform validation summary report reviews in an efficient and timely manner; including review of executed protocols, analytical data, and any supporting documentation to assure that they are compliant.

 

- Communicate with other departments on quality and compliance issues. Effectively communicate possible cGMP deficiencies and validation concerns with the appropriate departments.

- Review Non Conformance Reports for validation impact.

- Evaluate Change Control documentation for validation impact and determine validation requirements for that change.

- Stay current with changes to the Code of Federal Regulations (CFR) or FDA guidance documents so validation policies are current.

- Participate in meetings regarding marketed product or new projects and give input on QA issues related to validation.

- As required, assist in FDA inspections regarding marketed products.

- Participate if necessary and provide input with internal cGMP audits.

- Initiate new SOPs or revise existing SOPs for QA Validation as needed.

 

ABOUT THE IDEAL CANDIDATE:

- MUST HAVE experience executing protocols in at least Equipment and

Process validation (Solid dose environment is preferred.)

 

- MUST HAVE a Bachelor’s degree.

 

- Packaging, QC Lab, Cleaning, and Utility Validation protocol execution

experience is preferred as well.

 

- 4+ years of experience in a pharmaceutical environment with at least 3+

years of validation experience.

 

- Thorough knowledge of cGMP regulations including CFR 21 part 11.

- Excellent communication and technical writing skills.

 

- Ability to be flexible and to work efficiently and accurately to meet set goals

and timelines.

 

- Limited travel required.

 

  ABOUT THE COMPANY:

  - In operation for over 20 years.

 

  - Global Specialty Pharmaceutical Company

 

  - Has 11 Marketed US Products

 

  - $2.4 Billion in Annual Revenues

 

  - Domestic / International Locations

 

  - Equal Opportunity Employer

 

 

Qualified candidates should send a Word attachment of their resume to chris@newsomegroup.com .