Job for B.Pharm or MSc in R&D at Johnson & Johnson
Post : Executive, R&D Q&C
Role & Responsibilities :
• Supports R&D Q&C Lead in maintaining Quality System within the R&D environment.
• Conducts internal audits and GEMBA walks in analytical and microbiology laboratories
• Coordinates site inspection readiness activities
• Participates in nonconformances, out of specification and out of trend investigations to ensure that the root cause is appropriately identified, and robust CA/PA taken. Reviews and approves investigation and CAPA reports to ensure that documentation is complete and consistent to meet the GDP requirements.
• Reviews and approves GxP documents such as change controls, standard operating procedures, stability protocols and reports, test method validation/transfer protocols and reports, instrument qualification protocols and reports.
• Provides quality and compliance oversight of contract laboratories through periodic reviews of the contract laboratories’ quality system (deviations, CAPA, change controls, investigations)
• Conducts periodic reviews of computerized system validation
• Supports R&D Q&C Lead on supplier management (supplier audits/monitoring and preparation of quality agreements)
• Consolidates/analyzes quality metrics for Quality Data Review and proposes continuous improvements based on the analysis
• At minimum, B.Pharm or M.Sc. degree
• At least 5 years experience in Analytical and/or Microbiology laboratory, QC or QA functions in regulated Pharmaceutical or Consumer Health company; preferably with experience on managing foreign health authority inspections (US FDA and/or EMA)
• Knowledge of regulatory guidelines like ICH and USFDA
• Thorough understanding of data integrity requirements in Analytical and Microbiology Laboratories
• Experience of working on laboratory systems such as LIMS and Empower
• Analytical thinker and possesses strong problem-solving skills.
• Can easily learn computerized systems
• With strong communication and interpersonal skills.
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks.
• Demonstrate ability to challenge status quo.
Experience : 5 years
Qualification : MSc, B.Pharm
Location : Greater Mumbai
Industry Type : Pharma
Functional Area : R&D Q&C
Last date : 15th September, 2020
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube