Opening for Quality Assurance Executive @ 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: Quality Assurance Executive
Job Description
Position Summary: The involved QA position supports the R&D and Commercial stability activities on site with primary focus on the analytical method development /method validation /method transfer activities and registration and commercial stability related activities. The role involves interacting and aligning with global JnJ functions and leading escalations and representing site in global discussions. The role is individual contributor role supporting R & D or commercial stability lab.
Job Responsibilities
- Good understanding of regulatory guidelines (21 CFR, Eudralex, ICH, Indian D&C Act), correct interpretation and implementation of the same in actual practice
- Independently perform quality assessment of non-compliance trends, identification of training needs, and designs appropriate courses/solutions to address those needs.
- Quality systems knowledge like Handling of Deviations and Quality investigations, Change controls, CAPA, Trainings, Internal audits
- Review and Approval of GMP documents, SOP’s, Work instructions, protocols.
- Should be able to write SOP’s related to Quality Operations independently.
- Perform IPQC checks and GMP check rounds in manufacturing area with the objective of proactively addressing training needs. Provide training to shop floor personnel in manufacturing unit.
- Review of Batch Manufacturing and Batch Packing Record and handling of Batch release activities independently.
- Compiling of Quality metrics data and performing trend analysis.
- Sound knowledge of following key areas like Stability process, Method development and Validations, Method transfer, Cleaning validation, Equipment qualification and verification and life cycle management, Computerized system validation, Risk Assessment, Purified system validation, Environmental monitoring, Microbiology.
Technical Skills: Complete knowledge of the manufacturing aspects and Quality and Compliance requirements with substantial direct experience of working in Pharmaceutical Manufacturing plant (Multinational or leading Indian Pharmaceutical company).
Other Requirements:
- Good interpersonal and communication skills, computer literacy.
- Fluency in English.
- Independent fact based decision making ability.
- High energy levels to manage work of differing complexities and availability in different time zones for global teleconference
- Systematic & meticulous approach towards work
- Passionate to work towards achieving targets
- Good training proficiencies
- Flexible & adaptable to meet goals of organization.
Qualifications
Educational Qualification: Bachelor of Pharmacy (B.Pharm)/ Master of Pharmacy (M. Pharm) or any equivalent advanced degree
Approximate Years of Industry experience: At least 4-5 years of experience in Manufacturing and Quality Assurance with a minimum 2-3 years of core QA experience
Indicative Reporting Structure
- People reporting – None.
- Reporting to - General Quality Assurance Manager.
Click here to apply
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: Quality Assurance Executive
Job Description
Position Summary: The involved QA position supports the R&D and Commercial stability activities on site with primary focus on the analytical method development /method validation /method transfer activities and registration and commercial stability related activities. The role involves interacting and aligning with global JnJ functions and leading escalations and representing site in global discussions. The role is individual contributor role supporting R & D or commercial stability lab.
Job Responsibilities
- Good understanding of regulatory guidelines (21 CFR, Eudralex, ICH, Indian D&C Act), correct interpretation and implementation of the same in actual practice
- Independently perform quality assessment of non-compliance trends, identification of training needs, and designs appropriate courses/solutions to address those needs.
- Quality systems knowledge like Handling of Deviations and Quality investigations, Change controls, CAPA, Trainings, Internal audits
- Review and Approval of GMP documents, SOP’s, Work instructions, protocols.
- Should be able to write SOP’s related to Quality Operations independently.
- Perform IPQC checks and GMP check rounds in manufacturing area with the objective of proactively addressing training needs. Provide training to shop floor personnel in manufacturing unit.
- Review of Batch Manufacturing and Batch Packing Record and handling of Batch release activities independently.
- Compiling of Quality metrics data and performing trend analysis.
- Sound knowledge of following key areas like Stability process, Method development and Validations, Method transfer, Cleaning validation, Equipment qualification and verification and life cycle management, Computerized system validation, Risk Assessment, Purified system validation, Environmental monitoring, Microbiology.
Technical Skills: Complete knowledge of the manufacturing aspects and Quality and Compliance requirements with substantial direct experience of working in Pharmaceutical Manufacturing plant (Multinational or leading Indian Pharmaceutical company).
Other Requirements:
- Good interpersonal and communication skills, computer literacy.
- Fluency in English.
- Independent fact based decision making ability.
- High energy levels to manage work of differing complexities and availability in different time zones for global teleconference
- Systematic & meticulous approach towards work
- Passionate to work towards achieving targets
- Good training proficiencies
- Flexible & adaptable to meet goals of organization.
Qualifications
Educational Qualification: Bachelor of Pharmacy (B.Pharm)/ Master of Pharmacy (M. Pharm) or any equivalent advanced degree
Approximate Years of Industry experience: At least 4-5 years of experience in Manufacturing and Quality Assurance with a minimum 2-3 years of core QA experience
Indicative Reporting Structure
- People reporting – None.
- Reporting to - General Quality Assurance Manager.
Click here to apply
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