Incumbent is responsible for the technical training and the development of training plans to ensure colleagues are appropriately trained in the production of pharmaceuticals. Incumbent is responsible for tracking cross-training status of all employees across departments within operations. Incumbent will assess the quality of training provided by trainers and audit the effectiveness of Operations' training programs. The incumbent will develop and be responsible for Operations' Train-the-Trainer programs. Also provide support in evaluation of job proficiency against training requirements described in career ladders. The individual will track, support and conduct required CAPA training as needed. The incumbent will provide Right First Time feedback and training to all Operations' departments. Responsible for ensuring all operations are carried out in compliance with all applicable cGMPs and in a manner to ensure employee safety and product security. Individual will also provide guidance in the formulation of individual development plans to assist these personnel in achieving their optimum performance and personal goals. Must be capable of working independently to ensure day-to-day activities are carried out in support of the facility mission. Individual will team with Operations Management to provide support of MBR, SOP, and SDC revisions. Also will review MBRs and key in critical system data as required. Will also be responsible for performing compliance related tasks as required to support the Operations organization.
(Describe in a series of brief statements up to five of your primary job responsibilities or activities in descending order of importance.)
o Responsible for developing, managing, conducting and supervising training and development programs for operations employees. This includes new employee orientation, job performance training, Standard Operating Procedure training as well as cGMP quality/compliance training with the ultimate goal to achieve overall regulatory compliance, job proficiency and personnel development and advancement.
o Design and facilitate training materials using MS Office (PowerPoint) and audio visual materials.
o Translate technical manuals and documents and extract relevant information into training documents;
o This is an experienced position within the Operations Department that requires prior experience and advanced knowledge of solid dosage manufacturing with relevant packaging and/or manufacturing processes and equipment. This position will provide technical support as necessary for SOP revision and development, QA Investigations, MBR review, equipment qualification, etc.
o Directly monitor training needs as applicable to new procedure, revision and frequency training for all Operations personnel to adequately ensure only fully trained personnel are involved in the production of pharmaceuticals.
o Incumbent will assess the quality of training provided by trainers and audit the effectiveness of Operations' training programs
o Track, support and conduct required CAPA training as needed.
o Provide Right First Time (RFT) feedback and training to all Operations' departments.
o Develop and maintain Operations' Train-the-Trainer programs
o Monitor cross-training status of all employees across all departments within operations.
o Provide technical support in drafting and reviewing Standard Operating Procedures (SOPs) and Skill Demonstration Checklists (SDCs). Work with Operations Management to maintain and create QDCS workflows. Implement red line changes of existing SOPs as directed by Operations Management.
o Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
o Responsible to meet objectives while managing spending, labor and capital to budget.
o Work with Operations Management to support SDC process including management of training documentation, on-the-floor evaluation for consistent practices and final approval of successful process specific training completion.
o Provide technical support in revising Master Batch Records (MBRs). Work with Operations Management to maintain and create QDCS workflows. Implement red line changes to existing MBR's as directed by Operations Management.
o Support Operations Management in the training of updated SOPs and ; provide all necessary training forms and attachments required, coordinate training activities with SME to ensure all personel are adequately trained.
o Team with Engineering as new equipment is implemented or existing equipment is upgraded to ensure key technical equipment requirements are identified and highlighted to Operations personnel. Communicate and implement necessary SOP, MBR, and SDC revisions.
o As required, provide support to Operations management in the final review of MBR's. Ensure all SAP batch data is properly entered and MBR's are delivered to QA.
o Assist Operations Management as required to complete compliance related tasks.
o Performs other related assignments and duties as required and assigned.
Requires a BS degree in a related technical field combined with 10 years pharmaceutical supervisory experience.
Required Experience & Technical Requirements
Requires experience in a production, manufacturing environment (preferably in the area of solid dose pharmaceuticals). Incumbent must have a technical understanding of pharmaceutical processes in order to translate various technical materials into training documents. Prior training/facilitation and training program design/development, project management, and group facilitation skills highly preferred.
Must have ability to work in a cross-functional team setting to solve problems and to accomplish the facility mission. Strong computer skills, must be proficient in MS Excel and PointPoint and possess the ability create presentations that enhance training process. Must have good working knowledge of QDCS and SAP computer systems.
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com . No hard copy resumes will be considered.
Purdue Pharma L.P. - 10 months ago