Assist the Production Leader in assuring that Operational area complies with quality, safety, environmental policies, guidelines, Standard Operational Procedures (SOPs) and other standards. Responsible in the development and implementation of Quality, Safety and Environmental objectives for the Operational area. Support the inventory control activities for the Operational area.
- Support the Operational area in the review and/ or preparation of SOPs and forms to assure that they comply with the CFR 211 and applicable guidelines in the areas of quality, safety and environmental. Generates new specifications. changes or instructions, as needed. Develop and implement sampling plans for the production processes. Support the Process Leader in technical and/ or process evaluations as needed.
- Coordinate activities that are part of the investigation process, assigning related tasks to other support members. Perform Quality Notifications and accountable for making sure that root causes are properly identified and documented. Assist in the determination of the quality impact of an event. Identify and analyze trends, using statistical and/ or quality tools as needed. Responsible for ensuring proper identification and implementation of corrective and preventive actions. Follow-up for the completion of preventive actions. Responsible to maintain USP waster sampling program in the manufacturing area.
- Responsible for the plan and coordination of regulatory compliance and safety proactive programs to create proficiency in safe work practices and promote safety awareness among support members.
- Assist in the appropriate determination of safety equipment and safe work practices. Provides advice and assistance in the evaluation of safety and environmental opportunities and recommends appropriate actions. Perform S&E self-audits and inspections; track closure of recommendations. Support the Operational area in ensuring compliance with environmental regulations and procedures as applicable. Provide training and orientation as needed.
- Responsible for reviewing the production processes [i.e. manufacturing, packaging) to assure adherence to current Good Manufacturing Procedures (cGMP’s), MPDs (Manufacturing Process Description). SOPs and OSHA regulations. Perform self-assessments, as needed, in the areas of quality, compliance and safety. Prepare the responses for internal audits and develop action plans as needed. Coordinates and evaluate any data trend as results of CPV (Continuous Process Verification) or APR (Annual Product Review) as needed.
- Support the Operational area by developing and providing technical training and in areas related to quality and regulatory compliance, including but not limited to quality matters, sampling plans, safety, human behavior, documentation trends and environmental.
- Willing to work irregular and/ or rotating shifts.
- Support the inventory control activities, assuring that adjustments in quantity and/ or investigations related to out-off limit accountability are done as needed. Assure that material reconciliation is done against SAP; that transactions are performed and Work-Orders are closed.
- Accountable for the compliance with cGMP’s, Safety, Health, Environmental, Local and Federal Labor, and Industrial regulations.
- Mentors members under his/her supervision, provides input and coaching on professional development and career path; provides timely feedback, evaluates performance of direct reports after obtaining the relevant functional input and evaluation.
- Perform any other job related duties as required or that may arise in the future such as support technology transfer, process development and launches.
- Comply with all environmental trainings, procedures, guidelines, practices, cGMP’s, permit conditions and internal notifications of any environmental event.
- Perform any other job related duties as required or that may arise in the future.
Education and/ or Experience
- Bachelor Degree in Science, Pharmacy or Engineering.
- Minimum of 3 years of production, quality or compliance experience in a highly regulated manufacturing environment, such as pharmaceutical and/ or medical devices.