Johnson
& Johnson Private Limited Hiring Executive, R&D Q&C B.Pharm or M.Sc. degree Apply Now
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
Qualifications
Education,
Experience, Knowledge Skill and Ability Requirements
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.
TO APPLY CLICK HERE
FOR MORE JOB UPDATES
No comments:
Post a Comment