Perform review of R&D GMP documentation and audits of the R&D GMP areas to ensure compliance to cGMP’s and SOP’s. Establish and maintain the GMP and SOP training program for R&D personnel. Support the Vendor Management Program in sourcing and assessment of new Raw Materials for R&D projects (APIs, Packaging Components and Excipients). Ensure effective and timely collaboration with R&D teams in support of R&D project objectives and timelines.
Duties and responsibilities
Review R&D GMP documentation for adherence to the GMP regulations and SOP’s
Periodically audit R&D GMP activity areas for compliance to cGMP’s and SOP’s.
Approve R&D manufacturing batch documents for validation, exhibit and clinical GMP batches.
Approve executed batch documents: (MF and PWOs), RMs, Packaging Components, Packaged Product COAs and Clinical COAs.
Manage the Training Program for R&D. Develop and maintain employee specific training curriculums.
Revise/review SOPs and Forms for biennial reviews.
Prepare for Pre-Approval Inspections (PAI’s) and audit all data for projects identified for the inspection.
Administer R&D Change Control System and R&D electronic documents: SOPs, Testing methods, forms, specifications.
Foster strong relationships with key Pharma and/or Private Label customers and Vendors.
Interact and provide feedback to Pharma and Private Label customers and Vendors concerning all quality systems, change control notifications, product environments and laboratory results.
Prepare and maintain Quality Agreements.
Respond to customer and vendor queries and notifications within the scope of the quality agreement or SOP.
Onboard of new contract manufacturers and maintain approved contract manufacturers through processing, review and assessment of change controls, specifications, master documents and quality agreements.
Lead and/or Participate in Recall activities.
Participate in and/or lead Non-Conformance Investigations as related to Customers or Vendors.
Perform risk assessments (as needed) for material/component/vendor related issues.
Evaluate Vendor performance to determine initial approval and continued status.
Minimum of B.Sc. Chemistry or other associated discipline.
5 - 7 years’ experience in Quality Assurance/Quality Compliance experience in the pharmaceutical industry environment.
Sound knowledge of R&D processes applicable to Pharmaceutical Industry.
Thorough knowledge and understanding of the USP, BP, Ph.Eur. test requirements, GMP-s, as well as FDA, HC and ICH guidelines with regards to GMP.
Particularly good attention to detail.
Ability to work independently, with minimal supervision.
Good organizational skills and multi-tasking ability to meet R&D and Vendor management deadlines and objectives.
Excellent written and verbal communication skills.
Ability to manage internal and external requirements.
Strong problem-solving skills with ability recommend and implement strategies towards enhancing the quality standards of the department and facility.
Evaluation of customer’s requests without divulging company confidential information
University - Bachelor's Degree/3-4 Year Degree