We are currently seeking a QA R&D Specialist who will plan, organize, coordinate and direct all R&D activities related to the Quality Unit to ensure timely completion of the group's tasks. Manage and implement operational strategies to maximize efficiencies of staff, testing and budgetary resources, and R&D goals while complying with regulatory requirements.
1. Oversee the performance of all R&D Quality activities to assure that products and processes meet company and regulatory requirements.
2. Responsible for coordinating staffing to establish product and process quality consistent with department and company operating objectives (including financial goals).
3. Provide technical assistance and direction to all R&D groups. Interface with regulatory agencies in conjunction with new drug submissions and during routine audits, investigations and technical interchanges.
4. Develop, direct and implement validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements including product design control and qualification, manufacturing equipment and production processes, and including facilities, controlled environments, utilities, information systems, component production, preparation, compounding, filling, sterilization, finishing, packaging, labeling, and material handling.
5. Manage the performance of contracted Validation services and personnel for compliance to contract requirements, and conformance to schedule and budget.
6. Provide overall direction and expertise in the application of current good Commissioning, Qualification, and Validation practices in compliance with industry standards, corporate policy, and regulatory requirements.
7. Participate in product, process, and equipment process design reviews to ensure that quality and validation requirements are accurately and completely specified.
8. Review, approve, and maintain all quality related documentation.
To qualify for this position candidates must possess 6-8 years of Professional experience in the area of technical expertise with at least 5 years of experience in Pharma or Medical Device industry (FDA and ISO requirements). BS degree in Mechanical Engineering or related science is required. Advance degree and Industry Certifications preferred. Thorough knowledge of GMPs, GLPs, ICH and pharmaceutical products. Familiarity with requirements for submissions to regulatory agencies. Working knowledge of all phases of company manufacturing and laboratory operations. Sufficient human relations skills to effectively staff and manage relevant personnel and functions to assure that company goals and responsibilities are met. Excellent verbal and written communication skills (English). Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company. Computer knowledge. Good knowledge of Statistics and sampling plans and related software programs (e.g. Minitab). Good analytical skills. Interpersonal skills. Ability to meet deadlines. Good organizational skills. Must be able to work independently. Some business travel.
State or Province