About the company
The firm established in the year 1888 long back with the longest history and started with the production of alkaloid medicine with the medicine granules with a total sales of $2000. The firm have 130 years history and in 2020, it launched the Covid-19 and handling large volumes of tests. The firm have more a centaury of history in making the lives better, the firm have established the 160+ countries and have more than 109 thousand working around the world. The firm have the pipelines of products like Nutrition, Neuro modulation, Diabetes, Diagnostics and cardiovascular divisions. The company is Pioneering in neuro modulation and un precedent approach for diagnostic solutions. The firm have Similac, I-stat, Pedia sure, Ensure and Brufen.
About the Job
Location of the Job : Goa factory
Job Role and Responsibility
Should be able to review and approve specifications, standard operating procedures, trends, Technical Reports and Deviation Reports as per requirement, Packing Materials, Raw Materials, Intermediate Products, finished products, stability samples, consumable and inward water samples Reports.
Appropriately Handling, Operation, and maintenance of all computerized system software associated with instruments and documentation.
Able to Upkeep of Laboratory with respect to compliance and safety.
Needed To follow current GMP, safety & GLP norms in the laboratory testing areas respectively.
Required to have Awareness on current guidelines, policies, procedures, and techniques of quality control
Required to do the Preparation and review of Standard Operating Procedures, Standard Testing Procedures, Analytical Specifications, Method of analysis and Analytical Worksheet.
Necessary to review the Cleaning Activities and Sampling Activities and To ensure GxP compliance.
Actively maintain the Reserve Samples for Raw Materials.
Handling of the activities related to Qualification, validation, requalification and decommissioning of
laboratory instruments/ equipment.
Needed to Ensure appropriate work allocation to the all the team members in Raw Material and Packing
Material and ensure optimum utilization of resources.
Needed to well maintain cleanliness and its records in the laboratory.
Handling of daily temperature and Humidity monitoring of the stability Chamber.
Sampling of Raw materials, Packing Materials and Consumables review to be done.
Necessary to review routine calibration of the analytical instruments and perform the review of sampling and testing of Samples from water system.
Timely able to review analysis of the Raw materials, Packing Materials, Intermediate samples, finished
product and Stability Samples and other miscellaneous incoming samples.
Should be able to review the loading and withdrawal of the Stability Samples in the stability Chambers.
Able to maintain the Residual Samples for Raw Materials and Finished Products.
Required to review daily temperature and Humidity monitoring of laboratory.
Able to maintain Packing material testing and Sampling Area in compliance with safety.
Necessary to Review of quality control documents.
Candidate Responsible for receipt and inward the incoming materials in QC laboratory.
and effective review of alternate vendor development samples of Raw Material.
Perform effectively Any other work assigned by the Manager.
For Compliance readiness - QA
Location of the Job : Jhagadia
Experience : a Minimum of 5+ years of experience in QA/R&D/ Supply chain, Manufacturing or QA Audits and inspection or related QA experience required
Education : Needed to have a minimum of Bachelors degree in physical or life science or engineering or business, but masters degree would be preferable.
Job Role
Required to Work with the sites and other functional groups to determine best in class replication opportunities within the Quality systems.
Effectively Partner with the sites through assessments and simulations to determine and mitigate areas of high risks.
Needed to Assists the sites, in coordination with quality system owners, in remediating and establishing action plans on critical and major audit findings.
Required to take the Overall responsibility is to assure that the AN global Quality system is effective in accordance with FDA, ISO and country specific requirements as well as AQR global policies.
Able to Assists in assuring that Quality System Owner Program and corresponding cadence of governance are established and effective in assuring robust quality system impact assessment to mitigate recurrence of compliance and product risk.
Needed to Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
Effectively Assists in reviewing Global Quality System health for improvements and opportunities. Develop insights, short term, and long-term goals to sustain Quality system health improvements.
Able to Assists in onboarding new Quality System Owners and Compliance Officers.
Needed to be expertise and Liaises with interdivisional team in external audit community of practice and manage external audit lifecycles with AQR to close all audits.
Required to Assists with food facility registrations and work with Regulatory Affairs and sites to ensure registration submissions are timely and accurate.