Hospira is the world's leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we are uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. Through our offering of high-quality, lower-cost generic medications, we continue to help reduce the overall costs of healthcare — to improve both the affordability of care for patients and the financial strength of the global healthcare system.
Post : Manager-Training Remediation
1. Remediation Activities
· Lead the overall training remediation program for both employee and contractor training. Design and execute processes to remediate gaps in training records, training syllabus, training SOPs, training materials, on the job training, etc.
· Provide technical expertise to plant / quality management which defines and implements an effective training system compliant with the CFR's and meets the business needs of the organization. Broad latitude is afforded for the incumbent to define and direct a training staff which designs, develops, implements, and measures training interventions to ensure that employees are competent to perform their jobs
· Be an SME on the entire site training program and interface with regulatory agencies during inspections
· Provide periodic updates to executive steering committee and site remediation team on training remediation progress. Proactively highlight and report compliance or execution risks and mitigation actions
2. Implementation of e-Learning System
· Support the global business technology and local site team in the implementation of the e-learning system at the site
· Upon implementation of the e-learning system, champion the process in using and maintaining the system and also mentor/ coach/train site staff in using the system
3. Maintain Training Compliance and Effectiveness
· Maintain the highest standards for training compliance across all functions at the Aurangabad site by ensuring that training & training records of all employees and contractors are in compliance with all applicable regulations, policies and procedures
· Conduct effectiveness checks for the actions / processes implemented and develop a set of effectiveness metrics to measure the state of training compliance
4. Capability Development
· Identify short and long term training requirements to provide new skill development and to correct skills deficiencies in pharmaceutical compliance operations
· Train Hospira / Pfizer employees on the Regulatory Requirements, Corporate Quality Policies, / Procedures. Act as a resource for all departments to help facilitate an understanding of the Global Quality Compliance requirements, and help develop innovative programs, which meet the requirements and help, meet Hospira / Pfizer Quality objectives
Skills/Experience Education/Certification
Perform other related duties as assigned or required
B.Pharm or M.Pharm/M.S. (preferred), with specialization in Pharmaceutics or Industrial Pharmacy
6-8 years of industry experience with 2 years supervisory experience in an advanced area (preferably cGMP Training) and 4 years of pharmaceutical experience with a good understanding of the regulatory requirements within the pharmaceutical industry.
Additional Information:
Experience: 6-8 Years (Manager)
Qualification: B.Pharm, M.Pharm, MS
Location: Aurangabad API
Functional Area: QA
Employment Type: Full Time
Job Type: Salaried
Req ID: 21066BR
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