Robert Watts Email & Phone Number

Pensacola, Fl, Us

Lincoln, Ri, Us

Led all aspects of Quality and Regulatory to include responsibilities of Quality Assurance, Quality Control, Microbiology, Regulatory, and Batch Release groups. • Actively worked with FDA 483 and Warning Letter responses. Worked with consultants to determine best remediation plans. Ensured plan implementation based on criticality and importance.• Managed up to seventeen direct reports. Set priorities as needed to meet customer timeframes and expectations. Determined key personnel and established backups for each. Coached team members for growth and improvement. • Worked with private equity ownership and executive management team providing key updates to 483/Warning Letter, critical investigations with anticipated closure times, hiring and retention needs, and business plans.• Worked with customers to understand their concerns about Quality issues. Created numerous customer communications that detailed major events affecting their products, investigation updates, and 483/Warning Letter submission updates.

I was responsible for all Quality Assurance and Quality Control activities. In addition I worked with other departments to assist with alternate raw material reviews and validation, investigation completion, and process improvements. I worked with contract customers to ensure the quality of their products and also with quality planning with their new product launches.

Responsible for all QA and QC activities

Responsible for all Quality functions.

Directed and coached multiple groups including Change Management, Training, Label Control, Incoming Materials and Component Release, Document Control, Document Review, Complaints, Investigations, and Corrective and Preventative Actions. Worked with private label customers for product launches and issue resolution.Worked with internal customers to ensure timelines were met, make process improvements, and act as a resource to others. Actively participated in Health Authority Inspections and customer audits and ensured proper resolution of any observations. Worked with Validation personnel to determine best processes for both manufacturing and cleaning validations.

Canonsburg, Pennsylvania, Us

Directed and coached multiple groups to include change controls, batch record and packaging record reviews, batch documentation issuance, in-process sampling and testing, supplier and component issues, and warehouse investigations. Worked with contract manufacturers and packagers to ensure timelines were met.

Canonsburg, Pennsylvania, Us

Managed and mentored the Floor Adherence Group to ensure GMPs and SOPs were complied with in the manufacturing, packaging, and physical testing laboratories. Participated in Health Authority and customer inspections. Provided team oversight and response to any incidents that occurred on the floor to determine the next course of action.

Canonsburg, Pennsylvania, Us

Created and grew a team from one to a team of four. Wrote and approved all Process Validation protocols and reports for Commercial, Product Development, other Mylan facilities, and contract manufacturers and packagers. Validations included new product launches, batch size or process changes, and new equipment.

Canonsburg, Pennsylvania, Us

Performed in-process sampling, physical testing, and cleaning validation swab collection.

Arlington, Virginia, Us