New Process Validation Manager

Responsibilities:Establish and execute policies and procedures that meet validation specifications for assigned facilities. Review and approve Validation reports for cGMP compliance and current regulatory/validation expectations. Assure processes and systems are performing in compliance with cGMP, state and federal guidelines. Evaluate vendors supplying raw materials. Evaluate changes to manufacturing processes and product formulations.  Determine validation requirements for changes in processes. Oversee change of control procedures to ensure applicable changes to validation processes and systems are properly documented, reviewed and approved before implementation. Function as regulatory interface for all cGMP, Validation, Compliance issues to include FDA communication, presentation and negatiating.  Support all local and national FDA inspections affecting approval, review and recall coordination. Assure rationale is documented for any decisions that deviate from regulatory guidelines, technical monographs or procedures that are applicable to drug manufacturing or control facilities. Manage and train personnel.

 

Minimum Qualifications:BS Engineering, Pharmacy or Life Sciences with training in cGMPs, Validation, Manufacturing Process, Technical Writing and Negotiating Skills. 7-10 years related experience in pharmaceutical industry, specializing in solid oral dosages. Working knowledge of PC languages and software applications (MSWord, Excel, PowerPoint, Network functions, etc.)  Mastery of statistics and application to the pharmaceutical industry.  Knowledge of pharmaceuticals, pharmaceutical manufacturing (solid oral dosage) and engineering is required.

 

Certifications or Licenses Preferred:

Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Professional Engineer (PE), Registered Pharmacy License, etc.