Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. Baxter had 2012 sales of $14.2 billion and has approximately 50,800 employees.
Post: Sr Mgr Plant Quality
Job Description
Responsible for ensuring GMP & regulatory complaince at the Site as per Baxter internal standards and applicable regulations.
Ensuring that processes/ equipment/ Facility are maintained in a validated/ qualified state. Ensure that periodic qualifications/ validations are conducted as may be necessary
Representing the site in Internal & external GMP Audits and implement & monitor calibration schedule
Conducting Self Inspections as may be required
To lay down sustain & improvise the Quality Management System and maintain highest level of Integrity of documentation & decision making.
Review & approve required SOPs, Protocols, Records, Reports & any other documentation as may be necessary for GMP compliance.
Implement effective & compliant system for release / rejection decision of input materials, inprocess & finished goods and components
Implement an effective complaint management system in compliance with Baxter standards & applicable regulations
Support the global Supplier Quality Management System & ensure the compliance to teh same
Participate in risk assessments, change assessments, CAPA investigations, Failure investigations and implementation of necessary remedial actions & their effectiveness checks
Monitor the regulatory license status & maintaining the applicable licenses in coordination with Regulatory Affairs Department
Implement an effective GMP Training Program
Motivation & Skill Development of team
Effective communication & coordination with various stake holders at manufacturing site, Business representatives, and applicable internal & external stake holders
Effective colaboration with Quality Representatives from regional & Global Quality organization
Participating & providing necessary inputs for management initiatives & improvement programs from time to time.
Qualifications
Gradute or Post Graduate in Pharmacy or Sciences (Chemistry/ Microbiology/ Biochemistry/ Biotechnology)
Minimum 12-15 years experience working in a reputed Pharmaceutical company, with minimum 3 years experience in a sterile product manufacturing setup. Minimum 3 to 5 years experience as a people manager with reasonable team size.
Knowledge of WHO, PIC/s, USFDA, EU GMP & Indian GMP regulations. Experience of facing audits from recognized foreign GMP regulations.
Problem solving skills, Solution Centric Approach & Aptitude to effectively handle challenging situations in a ethical manner.
Decision making capabilities in ambiguous situations, ability to take calculated risks.
Ability to effectively coordinate with various peer functions and manage cross functional priorities without affecting quality compliance requirements.
Should be self driven & able to lead by example, should be able to motivate and encourage team during challenging situations.
Additional Information:
Qualification: B.Pharm, B.Sc
Location: Manesar, Haryana
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
Job ID: 166967
End Date: 10th September, 2015
See All B.Sc Alerts B.Pharm Alerts Chennai Alerts
See All Other Jobs in our Database
.png)
