Vacancy as Executive Quality & Compliance in Johnson & Johnson

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Post: Executive Quality & Compliance

Job Description
1. Oversight & governance to ensure Quality & Regulatory Compliance in all products, processes & systems, at the External Manufacturing plant, in accordance to the Local Regulations and J&J requirements.
2. To ensure timely & effective deployment of the remediation plan/efforts in all aspects of GMP (including Facility, Equipment, Utilities, Materials, Processes, Quality Systems, Documents, People Capabilities etc.) at the External Manufacturing plant to bring it up adherence to an Acceptable status of GMP/Quality/Regulatory Compliance requirements.

General Responsibilities:
1. To ensure implementation of the Food Safety and Quality Management System; and reviewing it periodically for the adequacy & effectiveness.
2. To ensure compliance to Internal, External & Statutory compliances viz., J&J Quality Policy & Enterprise Standards & Global/Regional/Local Procedures, FSSAI & Legal Metrology etc.
3. To ensure all products conform to the established specifications, through validated processes, good manufacturing practices, validated test methods, robust documentation and various other checks & measures, prior to releasing the products from the External Manufacturing site.
4. To conduct periodic assessments/audits to identify gaps/improvement opportunities for strengthening the Quality & Regulatory Compliance. Prepare remediation/mitigation plan (CAPA) and execute it in a timely manner by coordinating cross-functionally to uplift the level of compliance.
5. To strengthen Laboratory Controls for timely & reliable testing of all incoming materials (Raw & Packaging), Intermediates, Bulk & Finished Products, critical utilities (Process Water, Steam, Air, Gases etc.), in accordance to the relevant specifications, using validated test methods & qualified equipments.
6. To conduct periodic training related to Quality, GMP, Regulatory aspects, for all functions/departments in the ambit of GMP and evaluate its effectiveness.
7. To review & authorize/approve all the Quality records (viz., Batch Manufacturing Records, Test Reports, Validation & Qualification Protocols/Reports, etc.).
8. Responsible for leading the on-site investigation of Non-conformances, Deviations, Market Complaints etc. and establishing/deploying a robust CAPA to avoid recurrences.

Qualification:
1. Education: Graduate/Post-graduate in Food Technology / Chemistry / Microbiology / Bio-Chemistry.
2. Sound technical knowledge of: HACCP, ISO 22000, PAS 220 standard, GMP, Water Treatment Plant, Aseptic Food Processing, Analytical & Micro Lab Operations etc.
3. Experience: Around 5 – 7 years in a reputed Food Manufacturing Plant (Preferably non-alcoholic beverages)
4. Candidates with ISO 22000 Lead Auditor Certification (Food Safety Management & Analytical Skills) will be preferred.
5. Candidates located in Guwahati or Bangalore will be preferred.
6. Good communication & interpersonal skills, flair for quality, team player, quick learner.

Additional Information:

Experience: 5-7 years

Qualification: Graduate/Post-graduate in Food Technology / Chemistry / Microbiology / Bio-Chemistry

Location: Assam

Functional Area: QA

Industry Type: Pharma/Biotech/Clinical Research

End Date: 25^th September, 2015