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Post : Manager/ Trainer for Pharmaceutical QA & GMP Training
Job Description
This is a non-supervisory professional fixed term contract position responsible to support the various activities of Pharmaceutical Training and Education, in coordination with the senior faculty, USP Pharmacopeial Education (PE) and training department. Activities primarily include current good manufacturing practices (cGMP) training to fresh graduates/beginners, industry representatives: working with course leads (SMEs), external cGMP consultants/speakers, PE coordinator in India and USP-Rockville.
Roles and Responsibilities:
• Acts as the India site Subject Matter Expert (SME) for Quality Assurance (QA) /cGMP Training curriculum
• Reviews specific cGMP/QA training curriculum in conjunction with course leads/SME and external consultants prior to course delivery
• Delivers cGMP training on various QA modules across India per the work plans and schedules developed by PE department
• Monitors evolving cGMP regulations, standards and guidance, interprets relevant information and takes appropriate actions or propose recommendations to modernize the previously developed content, as necessary.
• Participate and deliver “Train the Trainer” program with course developers and standby speakers.
• Assist PE coordinator in India for collation of training materials, job aids, checklists and other materials necessary to deliver training
• Collects, analyzes and prepares training effectiveness metrics based on the feedback received from the participants, site management and implement actions to enhance the performance of course delivery.
• Ability to represent the training department as a SME to customers, consultants and other workshop organizers
• Assist in meeting PE departmental goals and multiple training projects as needed.
• Willingness and ability to travel different domestic locations.
• Perform other duties as assigned.
Candidate Profile
• Master’s degree in Chemistry/Pharmacy and at least 8-10 years of experience in QA plus QC (or) QA plus Regulatory Affairs in pharmaceutical industry preferably in both API and finished formulations.
• 2-3 years of GMP trainer experience in QA is a must.
• Must have thorough understanding on cGMP, GLP, and ISO regulations and the integration of the regulations into working systems/concepts in the QA. Specifically, good documentation practices, Internal audits, Change control, Deviation, CAPA, OOS, process/cleaning/equipment validations etc.,
• Understanding of USP’s monographs/general chapters/general notices is a plus
Required Experience
• Must have hands on experience working with QA and cGMP Training. Working experience in QC (or) RA prior to QA is a plus.
• Excellent English proficiency both verbal, written, presentation and communication skills required.
• Ability to work with virtual teams in remote location.
• Must be able to communicate effectively with articulation of thoughts, spontaneity to diverse audience.
• Should have deep understanding of cGMP guidance/regulations (ICH, 21 CFR, EU GMP, WHO, PICs).
• Working knowledge of computer applications, such as MS Word, MS Power point and MS Excel.
• The physical requirements for this position generally include: standing, walking, sitting, using hands and fingers, talking and hearing to engage the audience.
Additional Information
Experience : 2-10 years
Qualification : M.Sc, M.Pharm
Location : Hyderabad, Andhra Pradesh
Industry Type : Pharma/ Healthcare/ Clinical research
Tracking Code : 1175-679
Functional Area : Pharmaceutical QA & GMP Training
End Date : 15th September, 2018
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