Healthcare Assessor

2 months ago


Mumbai, India BSI Full time

Great that you're thinking about a career with BSI

Purpose of Position

The purpose of this position is to lead and manage the development of the BSI sector strategy in Healthcare and Pharmaceutical by packaging BSI’s product and services portfolio including but not limited to:
- Good Manufacturing Practice (cGMP)- ISO9000, 1S0 14000, ISO45001,, ICH guidelines, PSCI, GDP- Training- Supply Chain Verifications (Quality, Social, OHSE, Security), Tools and Solutions

Key roles are available for Sector Managers, Auditors and Tutors or a combination of both depending on the applicant’s skills and experience. BSI is committed to building strong sector teams of professionals at a country and regional level therefore is looking for Sector Managers, Auditors and Tutors in the Healthcare/Pharmaceutical sector.

Applicants will be part of a dynamic team of specialist involved in developing the strategy, building BSI Auditor (Client Manager) and Tutor capacity and capability, client acquisition, technical support and service delivery of cGMP assessments, ISO Standards (9000,14000,, 45001), Supplier Verification Services (client specific programs - Quality, Social, Security, OHSE) and related training activities.

Key Responsibilities & Accountabilities- To provide Healthcare-Pharma understanding of Good Manufacturing Practise (GMP) and relevant regulations concerning the manufacturing,, and distribution of products and their active ingredients.- To help develop standard operating procedures for the sector and client specific cGMP or Quality compliance Standards, checklists, guidance documents and training material for internal and external stakeholders including auditors and clients.- Support with the recruitment, on boarding and training of BSI auditors and Tutors- Develop and implement capacity and capability building training plans to ensure adequate professional resources development to deliver compliance audits and accredited cGMP related training- Implement and train team members to follow company standards operating procedures (SOP), client operating procedures (COP’s) and common operating model.- Manage your own professional development and multi-skilling plan for defined certification schemes relevant to the Healthcare-Pharma sector (ie GMP, HACCP,, ISO9000, 14000, 45001,, Supplier Verification)- Conduct onsite assessments to GMP, ISO Standards and/or client specific requirements- Conduct training activities, both public and in-house to GMP or ISO Standards or client specific requirements as defined by the sector strategy and or area of expertise and qualification- Act as a Brand Ambassador for BSI and comply with the BSI Golden Rules. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”. BSI Golden Rules include:
- Be the BSI Brand Ambassador-
- Work with scheduling and planning to ensure your work is booked three to six months ahead-
- Produce a high-quality, accurate and professional client report-
- Complete the client report onsite before you leave-
- Closing meeting - before you leave, discuss Driving Force opportunities and book the next visit-
- Upload the e-report within 48 hours of the client visit-
- Be 100% productive and aim to exceed your delivery target-
- Maintain and gain more Tutor, Product, Industry codes - own your professional development-
- Be part of the BSI team - be in the office when you are not with clientsBe part of the solution for continuous improvement by providing feedback as to how BSI can “Make Excellence a Habit”.Knowledge / Skills / Abilities- You will be educated to degree level in Chemistry, Biology, and Engineering, Pharmacy sciences or similar field preferred or have a further education diploma/graduation/postgraduation with proven experience in pharmaceutical/Healthcare/ manufacturing, or laboratories. Experience in conducting and delivering assessments, including GMP/HACCP/FMEA/QA/QC/Compliance is essential as is experience with Healthcare/Pharmaceutical or and development processes.- In-depth know-how of specific GMP/HACCP, HSE topics such as Industrial Hygiene, Biological or Chemical Hazard, Hazardous Waste Management, and Process Safety Management together with the associated regulatory environment- Qualification in a minimum of Three (3) of the below standards shall be a pre-requisite for applicants being considered for the role.- GMP (Good Manufacturing Practice) for Food or Healthcare or Medicine-
- HACCP (Hazard Analysis Critical Control Point)-
- ISO 9000 (Quality)-
- ISO 45001 (Occupational Health and Safety)-
- ISO 14000 (Environment)-
- Supplier Verification to client specific programs (Quality, Safety, OHSE, CSR, Security)-
- Tutor Training with Train the Trainer (TTT) Qualification and any of the above schemes-
- Experienced presenter who is able to deliver training on GMP for in-house and public training courses would be hig



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