Job responsibilities:
- Enforce compliance of current Good Manufacturing Procedures standards including in reviewing documentation related to product processes including batch records, validation protocols, and Standard Operating Procedures.
- Ensure and enforce compliance with GMPs, DEA, OSHA regulations, SOPs, Master plans, Batch records, Ingenus Policies and industry standards.
- Responsible for scheduling production activities with management according to the Sales Order and Order Forecast.
- Handling day-to-day activities on the shop floor and ensuring that good manufacturing practices are being followed by working subordinates.
- Provide support to the operator, group leader and supervisor in the daily management of the department activities.
- Responsible for ensuring documentation timelines and perform risk assessments and root cause analyses to address deviations and non-conformances.
- Collaborating with cross-functional teams, including research and development to resolve.
- Ensure accurate system inventory is maintained through the performance inventory reconciliations, facilitation of material delivery review, and other related activities.
- Conduct internal investigation related to product failure deviations.
- Lead safety related programs.
- Write safety incident reports, near misses and take corrective actions.
- Plan and lead manufacturing process improvements and other LEAN initiatives to optimize performance and drive short and long-term business improvement.
- Conduct internal investigations relating to quality, safety, and personnel. Establish and maintain document numbering, version control, and revision history for all production documents.
- Coordinating document movement across all functional groups Imparting training to new employees and other subordinates.
- Ensure that all documentation related to each task above is performed as per the operating procedure.
- Ensuring the availability of Materials for manufacturing process and co-ordination with Quality control, Quality assurance and Engineering departments for smooth flow of manufacturing and packaging operations.
- Maintain accurate and up-to-date manufacturing documentation. Review history documentation for accuracy and product release. This position supervises others.
Requirements:
- Applicants must have a Master’s degree (or US Equivalent) in Pharmaceutical Science, Pharmacy or related field.
- Must have two (2) years’ experience in pharmaceutical production.
- Experience in Good Manufacturing Practices (GMP), and regulatory standards including FDA, MHRA, and WHO guidelines is required.
- Must have a detailed understanding of effective scheduling, estimating, and workflow processes in a generic pharmaceutical environment.
- Hands-on experience in pharmaceutical manufacturing processes, specializing in solid dosage forms such as tablets and capsules, as well as liquid formulations.
- Experience with ERP systems, Pragma platforms, Standard Operating Procedures (SOPs) and batch manufacturing records documentation.
- Demonstrated experience in initiating and reviewing written procedures such as standard operating procedures (SOPs), operating instructions, cleaning procedures, safety procedures, and other work procedures is required.
- Experience in Production Planning & Scheduling, Supply Chain Coordination, Lean Manufacturing / Six Sigma, CAPA Management (Corrective and Preventive Actions) and Resource Allocation (Man, Machine, Material) are required.
40 hours per week M-F: 9:00 a.m. to 5:00 p.m. Must have proof of legal authority to work in the United States. Salary: $129,189 – $132,000 per year. To be considered, please visit Ingenus Pharmaceuticals’ career website at https://www.ingenus.com/careers/ and apply by emailing your resume to hr@ingenus.com. Job Number: 52026
To apply for this job email your details to hr@ingenus.com