Baxter Quality Assurance Lead DVM in Sweden, Sweden



Quality Assurance Lead DVM Our employees around the world are connected by an enduring commitment to save and sustain lives. This higher purpose binds us as a company in doing work that matters .
Do you want to know more about to work for Baxter? Go to https://www.youtube.com/watch?v=OY89yj_zSIo

The Job With regards to Lund DVM Department

  • Ensures compliance with the Manufacturing license, local regulatory requirements, cGMP and Baxter standards and policies;

  • Lead the implementation, monitoring and maintenance of Baxter Quality System;

  • Is responsible for the management of the release process; ensures product meets specification and customer order/ prescription prior to release;

  • Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality

    ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Management

    + Management of performance against assigned objectives
  • Product Release

  • Ensure batch record review, enclosing associated environmental data and NCR/quality incidents

  • Based on batch record and NCR review, propose batch to release to the responsible Pharmacist Quality system Management

    o Change Control

    + Ensure application of Change Control system to the department, making sure that all changes are assessed for their impact to regulatory compliance and product safety, in accordance with the quality system and appropriate controls are established to facilitate compliant management of the change

    o Complaints

    + Ensure all complaints reported by customers are appropriately documented and investigated as required + Ensure all complaint investigations content meets cGMP regulation and corporate standards + Responsible for ensuring all complaints are closed within the specified corporate time frames + Responsible for reporting immediately any complaints that may result in Field Action to the Site Director and the EU QA Compounding Director + Responsible for reporting any adverse events to competent Pharmacovigilance

    o Document and Data Management

    + Ensure all documentation is relevant and applicable to the DVM process and is reviewed and updated + Ensure quality records relevant to the DVM dept are reviewed, complete, comprehensive, legible, compliant with good documentation practice + Ensure quality records are retained in such a way that they remain complete, comprehensive and legible

    o Non conformance

    + Manage the DVM dept nonconformance process in compliance to GMP regulation and Corporate procedures + Ensure that all deviations from documented processes and recorded and investigated + Review and approve all investigations + Ensure corrective actions are taken to prevent reoccurrence of the deviation + Ensure that any product affected by a deviation is formally dispositioned, ensures where needed product is segregated and rejected + Ensures no product is released before a formal assessment for the impact of the deviation is made and a disposition approved by the responsible Pharmacist

    o CAPA

    + Ensure formal CAPA’s are raised to investigate and take action to address deficiencies + Responsible for ensuring all CAPA are progressed and completed to the agreed time lines + Responsible for ensuring the content of CAPA meet GMP regulations and corporate standards + Responsible for DVM department CAPA Review Board process
  • Quality System Measurement and Review

    + Report relevant quality KPI to EU QA Compounding + Ensure systems are in place to track and trend quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers
  • Calibration, Validation and Routine Maintenance

    + Develops, manages and maintains the validation master plan for the DVM department + Review calibration and maintenance program + Review and approval of periodic/new qualification/validation protocols + Review and approval of periodic/new qualification/validation reports
  • GMP and Facilities and Equipment Control

    + Ensure all manufacturing operations comply with current GMP guidance + Supports training and communication of GMP requirements to all DVM department staff + Ensures that processes and procedures are in place to provide assurance that product is of a suitable quality for supply to customers
  • Audit Management

    + Act as QA representative/lead in all audit processes relevant to DVM department + Ensuring that audit findings are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue

    Communication and Training

    + Regularly communicates with all DVM staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance + Ensures that specific operational training is conducted with DVM department staff to enable them to complete their jobs in compliance with the Baxter quality systems and country regulations

Who you are

* At least 2 years’ experience of working in aseptic manufacturing

* At least 5 years’ experience of quality system implementation

* At least 2 years on the leadership position

* Ideally experience in all or any of the following:


o Aseptic Manufacturing of Sterile Medicines, Compounding, o Quality system management Environmental / microbiological control Validation

* Fluent in English.


Technical and personal skills

* Use of TrackWise 8 is a plus

* Report writing

* Personal accountability and sense of urgency

* Ability to work under stress conditions, to work with multi tasks in the limited time

* Verbal and written Communication skills

More information: This recruitment will be managed by Dfind Science & Engineering. For more information about this position please contact Recruitment Consultant Camilla Wern 0733-436098. The selection process is on-going so please apply as soon as possible, however not later than 2017.06.06. Please send in your application in English via https://www.dfind.se/science-engineering/





What we offer It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix of people. Joining Baxter means joining a team that you can truly learn from! We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers. If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you. If you want to learn more about career opportunities go to http://www.baxter.com/careers.page


Who we are Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide. You’ll find us in clinics and in the home. Patients and providers rely on Baxter for lifesaving renal and medical products. Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations for the world. Our 50,000 employees serve patients and clinicians in more than 100 countries and are dedicated to ensuring Baxter is there when patients need care. Our inclusive culture and a diverse workforce drives innovation, creates trusted partnerships with customers, suppliers, and community partners, and contributes to the success and sustainability of our business. Every day at Baxter is a chance to save and sustain people's lives. * Equal Opportunity Employer Discrimination: Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic . *

Quality Assurance Lead DVM Our employees around the world are connected by an enduring commitment to save and sustain lives. This higher purpose binds us as a company in doing work that matters .
Do you want to know more about to work for Baxter? Go to https://www.youtube.com/watch?v=OY89yj_zSIo

The Job With regards to Lund DVM Department

  • Ensures compliance with the Manufacturing license, local regulatory requirements, cGMP and Baxter standards and policies;

  • Lead the implementation, monitoring and maintenance of Baxter Quality System;

  • Is responsible for the management of the release process; ensures product meets specification and customer order/ prescription prior to release;

  • Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality

    ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Management

    + Management of performance against assigned objectives
  • Product Release

  • Ensure batch record review, enclosing associated environmental data and NCR/quality incidents

  • Based on batch record and NCR review, propose batch to release to the responsible Pharmacist Quality system Management

    o Change Control

    + Ensure application of Change Control system to the department, making sure that all changes are assessed for their impact to regulatory compliance and product safety, in accordance with the quality system and appropriate controls are established to facilitate compliant management of the change

    o Complaints

    + Ensure all complaints reported by customers are appropriately documented and investigated as required + Ensure all complaint investigations content meets cGMP regulation and corporate standards + Responsible for ensuring all complaints are closed within the specified corporate time frames + Responsible for reporting immediately any complaints that may result in Field Action to the Site Director and the EU QA Compounding Director + Responsible for reporting any adverse events to competent Pharmacovigilance

    o Document and Data Management

    + Ensure all documentation is relevant and applicable to the DVM process and is reviewed and updated + Ensure quality records relevant to the DVM dept are reviewed, complete, comprehensive, legible, compliant with good documentation practice + Ensure quality records are retained in such a way that they remain complete, comprehensive and legible

    o Non conformance

    + Manage the DVM dept nonconformance process in compliance to GMP regulation and Corporate procedures + Ensure that all deviations from documented processes and recorded and investigated + Review and approve all investigations + Ensure corrective actions are taken to prevent reoccurrence of the deviation + Ensure that any product affected by a deviation is formally dispositioned, ensures where needed product is segregated and rejected + Ensures no product is released before a formal assessment for the impact of the deviation is made and a disposition approved by the responsible Pharmacist

    o CAPA

    + Ensure formal CAPA’s are raised to investigate and take action to address deficiencies + Responsible for ensuring all CAPA are progressed and completed to the agreed time lines + Responsible for ensuring the content of CAPA meet GMP regulations and corporate standards + Responsible for DVM department CAPA Review Board process
  • Quality System Measurement and Review

    + Report relevant quality KPI to EU QA Compounding + Ensure systems are in place to track and trend quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers
  • Calibration, Validation and Routine Maintenance

    + Develops, manages and maintains the validation master plan for the DVM department + Review calibration and maintenance program + Review and approval of periodic/new qualification/validation protocols + Review and approval of periodic/new qualification/validation reports
  • GMP and Facilities and Equipment Control

    + Ensure all manufacturing operations comply with current GMP guidance + Supports training and communication of GMP requirements to all DVM department staff + Ensures that processes and procedures are in place to provide assurance that product is of a suitable quality for supply to customers
  • Audit Management

    + Act as QA representative/lead in all audit processes relevant to DVM department + Ensuring that audit findings are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue

    Communication and Training

    + Regularly communicates with all DVM staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance + Ensures that specific operational training is conducted with DVM department staff to enable them to complete their jobs in compliance with the Baxter quality systems and country regulations

Who you are

* At least 2 years’ experience of working in aseptic manufacturing

* At least 5 years’ experience of quality system implementation

* At least 2 years on the leadership position

* Ideally experience in all or any of the following:


o Aseptic Manufacturing of Sterile Medicines, Compounding, o Quality system management Environmental / microbiological control Validation

* Fluent in English.


Technical and personal skills

* Use of TrackWise 8 is a plus

* Report writing

* Personal accountability and sense of urgency

* Ability to work under stress conditions, to work with multi tasks in the limited time

* Verbal and written Communication skills





What we offer It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix of people. Joining Baxter means joining a team that you can truly learn from! We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers. If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you. If you want to learn more about career opportunities go to http://www.baxter.com/careers.page


Who we are Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide. You’ll find us in clinics and in the home. Patients and providers rely on Baxter for lifesaving renal and medical products. Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations for the world. Our 50,000 employees serve patients and clinicians in more than 100 countries and are dedicated to ensuring Baxter is there when patients need care. Our inclusive culture and a diverse workforce drives innovation, creates trusted partnerships with customers, suppliers, and community partners, and contributes to the success and sustainability of our business. Every day at Baxter is a chance to save and sustain people's lives. * Equal Opportunity Employer Discrimination: Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic . *

Job: *Quality

Organization: *Global Compounding Quality

Title: Quality Assurance Lead DVM

Location: Sweden-Sweden-Lund

Requisition ID: 170002KU