Robert Sharpnack Email & Phone Number

Currently serving as the VP of Quality at ECI Pharmaceuticals and BioRamo LLC, two non-sterile, pharmaceutical manufacturing sites located in Ft. Lauderdale, FL, were we manufacture tablets, capsules, liquids and creams. The VP of Quality works closely with the Director of Quality to manage a quality group comprised of (8) individuals, responsible for monitoring and assuring the quality of the solid oral and liquid dosage products manufactured at the two sites, as well as handling day-to-day operations. The VP of Quality also serves as the facilitator in hosting FDA and DEA inspections.

Atlanta, Ga, Us

Working with a group of (4) other consultants at a sterile pharmaceutical manufacturer where we provide on-floor oversight for the aseptic product filling on an Inova Syringe filling line, a RABS vial filling and lyophilization line, and an Optima Isolator filling line.

Port St. Lucie , Fl, Us

Duties included providing regulatory compliance oversight to the manufacturing activities to assure regulatory compliance oversight to the manufacturing operation. Oversee the review and where necessary revisions to all quality system procedures and assist the quality group with day to day activities. Also facilitated hosting successful FDA pre-approval and GMP inspections. Helped design and construct a negative controlled hormone containment facility.

Assisting Quality Validation by providing on-floor oversight and document review for qualification and validation activities for a new live yellow fever vaccine isolator vial filling line inside a BSL-2 boundary. Duties also included revising site procedures, assisting with improving media simulation activities and assisting by coaching SMEs during internal audits and regulatory inspections. In December, 2018 this line received both FDA and Canadian approval.

Working as part of a consulting team at a large vaccine manufacturer assigned to reviewing and coaching SMEs on process and laboratory test method validation activities.

Passed grade A gowning certification and serving as an on-floor QA in the aseptic filling area, performing room releases, observing manufacturing and filling as well as providing training to a group of newly hired quality auditors. Completed GMP training of newly hired manufacturing quality assurance (MAQ) personnel and finished the assignment.

Working with a small group of quality/compliance consultants at a large sterile medical device manufacturer to revise procedures and improve handing of deviations and complaints.

Served as the aseptic SME and member of an aseptic filling group that provided on-floor quality oversight, compliance remediation and assisted with emerging support system needs to better prepare for upcoming inspections. Recommended improvements to strengthen media simulations to bring them in alignment with the PDA tech report 22 and suggested improved personnel and material flows to better segregate controlled areas. Also served as one of the SME coaches during two regulatory inspections at sister facilities. Shortly after ending this project, the site's Warning Letter was withdrawn by FDA.

Worked with the Quality Group & PAI Readiness Team on a large vaccine expansion project involving two new syringe and a vial filling line, a new fermentation facility and a vaccine isolator aseptic filling operation. Responsibilities include performing quality review/approval of commissioning/qualification & process validation activities, providing regulatory guidance to the project team and participating as the SME coach on several successful PAIs. Also served as a coach for one of the deviation writing teams for approximately 6 months.

Primarily worked at a large sustained-release solid oral dosage manufacturing assisting with compliance remediation, deviation/investigation training and drafting process validation protocols. The facility subsequently received a successful regulatory inspection and was removed from OAI (official action indicated) status. During this time, also assisted a foreign pharma facility obtain PAI approval of a new expansion project.

Worked as a senior consultant with AAC Consulting, providing FDA guidance to the pharmacutical and clinical research establishments. Also worked as a senior compliance advisor at Kendle International, a full-service clinical research organization (CRO), and the parent company for AAC Consulting. Conducted internal/external audits and provided regulatory guidance to the clinical research staff .

Inspected sterile and non-sterile bulk (API), finished dosage pharmaceuticals, clinical research facilities and served as a district compliance officer and supervisory investigator.