Par Pharmaceuticals Work Values

Daily Duties at Par Pharmaceuticals:

Provided oversight of MQA (Manufacturing Quality Assurance) Specialists and ensuring that daily monitoring of manufacturing operations and areas is being performed to verify conformance with established company procedures and applicable regulatory requirements. Ensured timely completion of batch record reviews and audits of manufacturing areas. Interfaced with Quality Management Systems including but not limited to deviations, investigations, change control and CAPAs. Wrote, evaluated, and approved quality investigations and associated corrective and preventative actions (CAPA). Lead cross-functional teams to implement CI (continuous improvement) and Quality Initiatives Monitored employee performance & provided feedback; performs reviews and provided group performance metrics. Developed part 211 compliant system for trending data analyses of master batch record information Par QA Management representative for customer facility audits and documentation audits/reviews Lead Process Improvement person for AQL (Acceptance Quality Limit) program for Packaging and Inspection Department. Revised the batch record review process for manufacturing and QA Cross trained personnel in Lot Disposition and Product Release activities. Developed a robust training schedule/program for new hires Lead cross functional team to merge procedures and processes with industry and regulatory standards across the site QA Management contact for regulatory inspections and responses (FDA, EMEA, etc…) Performed SOP and Process revisions and improvements to Acceptable Quality Limit (AQL) process. Performed batch record approval for manufacturing use Performed various SOP and controlled document revisions Trained Investigator via on site Certified Root Cause Analysis Training

What they like about Par Pharmaceuticals:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

21 CFR Parts 210 , FDA/EMEA Inspections, Deviation Investigation, CAPA Management, Project Management, Root Cause Analysis, Clinical Research, Lot Disposition/Batch Release, Aseptic Auditing

Skills

Data Management, Aseptic Auditing, Root Cause Analysis, Regulatory Audits, Customer Audits, Deviation/CAPA Management, Tech Transfer, Clinical Research, Lot Disposition / Batch Release, Deep Understanding of 21 CFR Parts 210 & 211, Project Management, Aseptic Manufacturing

These are some of the questions we asked our climbers about their experiences with Par Pharmaceuticals: