Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world.
Post : Officer Quality Control
Job Description
• To ensure compliance of Good Laboratory Practices (GLP) & Good Documentation Practices (GDP) in Quality Control Analytical Laboratory.
• To co-ordinate Testing of sample through Public Testing Laboratory (PTL).
• Maintain lab compliance w.r.t. Data Integrity, Computer System Validation (CSV) and GDP.
• Procurement of lab supplies, inventory and services form approved vendors.
• Responsible to execute work done on Regional, Global and Enterprise initiatives in Analytical Laboratory and ensure Standard and Global Procedures are implemented.
• Responsible to maintain the laboratory all time Audit Ready for Internal and External Audits.
• To ensure operation, upkeep, qualification, calibration & maintenance of analytical instruments like HPLC, FTIR, UV-Vis Spectrophotometer, etc.
• Ensure timely closure of Quality control related investigations, CAPA, change controls OOS/OOT and market complaints.
• To coordinate shift operation activities in QC Lab.
• Responsible for training of self and Lab Training Management and to initiate and complete qualification process of Analyst.
• To review Lab Testing data and provide disposition status of Raw Material and Packing Material on time.
• Responsible for review and Maintenance of Volumetric Solutions and Reagents/ indicators used during analysis in Laboratory.
• Ensure Safe working practices are followed in lab as per EHS guidelines.
• Lab upkeep and 5S management in lab.
• To conduct and ensure on time sampling & testing for incoming materials, in-process materials/products and finished products being manufactured in the plant.
• Review & revision of applicable SOPs, RM, FP and PM specifications.
• Responsible for RM, PM & FG reference sample management.
• Responsible for management of shade cards.
• To reviews laboratory cleaning record and destruction of post analysis samples.
• Responsible for verification of periodic reviews of chemicals
Additional Responsibilities
• Actively participate in routine testing activities, as needed.
• Authors and revises procedures under minimal supervision. To take lead on document stream-lining.
• Follow all safety rules and regulations and conducts periodic safety audits.
• Follow all cGMP rules and regulations.
• Will perform work under minimum supervision and will provide oversite to projects and assist other Chemist as needed.
• To interact with chemists and other personnel regarding testing, procedures performed, related results and prepare reports.
• Works to learn and improve on others techniques and tasks.
• To performs data generation, analysis and problem solving with minimal rework.
• Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting.
• Works under minimum supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and applicable regulations.
Candidate Profile
• Master Degree in Chemistry, Bachelor’s Degree in Bio-Technology or related science discipline with 3-5 years of related work experience in Pharma , Healthcare Industry. Knowledge of cGMPs and related compliance regulations and guidelines is required. CTS requirement is Good to have.
• Must have the ability and skill to perform detailed job requirements noted above competently, safely and proficiently.
• A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
• Must have excellent organizational, verbal communication and technical documentation skills.
• Good computer skills.
• Knowledge of safe laboratory practices, proper knowledge of handling chemicals and samples.
• Must be a team player with high integrity and concern for quality of Company products, services and staff members.
Additional Information
Experience : 3-5 years
Qualification : M.Sc, B.Sc
Location : Maharashtra - Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Control
End Date : 20th June, 2021
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