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Post : Assistant Manager – QA Training & Education
Management : 1. Conducting CGMP and GDP training for all the employees working in Industrial operations for Medchal & MRP 2. Ensure On – the job trainings for all the employees. 3. Maintenance and archival of training records. 4. Coordination with cross functional teams for Quality Trainings. 5. Tracking of GMP trainings in order to ensure the compliance for Annual Training Calendar. 6. To ensure the trainer qualification requirements for Central Warehouse, ITS, HR at Medchal & MRP sites. 7. Dedicated source for conducting GMP/OJT for new hires of Contract workforce 8. Planning, Scheduling, Coordinating & Tracking GMP trainings 9. Coordination with HR for all trainings. 10. Ensure Training data – Questionnaires 11. Logistics for external trainings: eBuy, Transport and workshop handling
Quality systems and documentation: 1. Involve in investigation of Training related Deviations. 2. Involve in Implementation of Training related CAPA. 3. Involve in creation and implementation of Change Controls.
Management : 1. Deliver effective , timely CGMP and GDP training for all the employees ( new hires/ existing/ contractual workforce) working in Vaccines Industrial operations for Medchal & MRP 2. Ensure On – the job trainings completion for all the employees in coordination with transversal functions 3. Ensure effective maintenance and management of training records (up to date all times) and proper archival and ensure audit readiness in his/her area at all times. No data integrity issues and human error. 4. Ensure compliance of all Industrial operations employees to the Annual training Calendar 5. To ensure the trainer qualification requirements adherence and completion for Central Warehouse, ITS, HR at Medchal & MRP sites for Vaccines Industrial Operations. 6. Analyse data, Identify gaps with respect to QA related training/s in both sites, investigate the reasons, design appropriate solution to close those gaps with the training Head and drive compliance and adherence to schedule for both sites. 7. End to end training management and support for all types of QA training delivered in both sites 8. Logistics for external trainings: eBuy, Transport and workshop handling end to end 9. Lead the Audit preparedness and readiness for all audits for both sites from training management perspective 10. Should anticipate and plan effectively- training requirements for both sites and roll out training and calandar and tune to audit needs
Quality systems and documentation: 1. Investigate Training related Deviations. 2. Implement Training related CAPA and closures. 3. Create and implement Change Controls.
Knowledge, Skills & Competencies / Language • Proven ability to cooperate transversally • Proven ability to Act for Change • Well-structured way of working / thinking • Language requirements: Fluent speaking in English and Telugu • Should have good knowledge on Data Integrity and Human Error Prevention. • Should have good knowledge on aseptic processing, Contamination control, clean room behavior. • Should have good knowledge on current regulatory guidelines- DCA/ DCG/ CDL/WHO/ EU GMP • Effective coordination with cross functional teams for Quality Trainings. • Hands on delivering required trainings/ analytics/ reports
Candidate Profile • Minimum of Masters in Science or Pharmacy is required. • Minimum of 6 years of relevant experience in similar position in Pharmaceutical industry with injectable platform / sterile formulations. • This position requires excellent English language communication skills- spoken and written • Should be able to work independently with very minimal supervision. • Should lead and drive from the front for all Training management and execution and delivery • Should have good analytical skills – to analyze data and draw inferences and presnet to the QA department for effective decision making • This position requires excellent skills in MS office.
Additional Information Qualification : M.Pharm, M.Sc Location : Hyderabad Industry Type : Pharma/ Healthcare/ Clinical research Functional Area : QA Training & Education End Date : 10th September, 2019