Sr. Specialist, Quality Ecm

Baxter

2 years

Not Disclosed

Ahmedabad

10 Sept. 8, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🏷️ Position Title:

Sr. Specialist, Quality ECM
Req #: JR - 171758
Location: Ahmedabad, Gujarat, India
Apply Now | Save Job

🧭 Position Overview

This role is part of Baxter’s Global Quality team, supporting External Contract Manufacturers (ECMs) to ensure compliance with Baxter’s quality standards and global regulatory requirements. You will lead quality activities associated with technical transfers, audits, compliance, CAPAs, and more—making a direct impact on patient safety and product quality.

🎯 Key Responsibilities

🔗 ECM Management

Act as the primary Quality contact for assigned ECM partnerships.
Support onboarding of new ECMs to meet Baxter’s quality expectations.
Assist in the development and maintenance of Quality Agreements with ECMs.
Execute technical transfer activities with Product Quality and Design Quality teams.

🧪 Quality Assurance & Compliance

Ensure ECMs maintain a constant state of inspection readiness.
Participate in regulatory inspections and Baxter audits at ECM sites.
Conduct risk assessments, define mitigation actions, and monitor CAPA implementation.
Review and approve Annual Product Quality Review (APQR) reports for Baxter products at ECMs.

📊 Performance Monitoring

Define and track quality performance metrics for ECMs.
Report deviations, complaints, change controls, and ensure timely resolution.
Perform batch release responsibilities for products manufactured at ECMs.

🚨 Escalation & Issue Resolution

Escalate and manage ECM-related quality issues under the Field Action process.
Handle ECM Supplier Notice of Change (SNC) and assess potential product impact.
Execute Supplier Corrective Action Requests (SCARs) and manage quality notifications from ECMs.
Identify when escalation to SCARs/NCRs is necessary.

🔄 System & Process Improvement

Improve/develop Quality Management Systems (QMS) at selected ECMs.
Support SCAR closure, supplier compliance improvements, and regulatory readiness.
Collaborate with Supply Chain, Regulatory Affairs, Purchasing, and Quality Assurance teams across global Baxter sites.

📌 Qualifications & Competencies

🎓 Education & Experience

Bachelor’s degree in Science, Engineering, or related discipline.
Relevant experience in Quality Assurance, Compliance, or Contract Manufacturing environments (preferred in pharmaceutical or medical device industry).

💡 Skills & Attributes

Strong knowledge of QMS, GMP, and global regulatory standards.
Experience with technical transfer, risk management, and batch release.
Effective communicator with cross-functional and cross-cultural collaboration skills.
Strong attention to detail, critical thinking, and problem-solving skills.
Experience handling audits, CAPAs, complaints, and change controls.

🧬 Ideal Candidate Traits (Success Profile)

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

🌱 Benefits

Support for Parents
Continuing Education & Professional Development
Employee Health & Well-being Benefits
Paid Time Off
2 Days Annually for Volunteering

📍 Work Location

Baxter India – Ahmedabad Office
Navratna Corporate Park

Tower A, Ground Floor
Tower B, 21st & 22nd Floor
Ahmedabad – 380058
Gujarat, India

⚖️ Equal Employment Opportunity

Baxter is an equal opportunity employer. Applicants are evaluated without discrimination based on race, gender, religion, age, disability, or other protected characteristics.

♿ Reasonable Accommodations

Baxter is committed to providing reasonable accommodations for individuals with disabilities. For requests during the application or interview process, click here to share your needs and contact details.

⚠️ Recruitment Fraud Alert

Baxter has discovered employment scams involving impersonation of Baxter recruiters. To stay safe, review Baxter’s official Recruitment Fraud Notice.

📩 Ready to Apply?

Click here to Apply Now
Save Job | Share Job

Recommended Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Peru | Argentina |

Brazil :

Sao paulo | Brazil |

Attica :

Athens | Koropi |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Saitama | Japan |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

Ciudad de México | New Mexico |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Lyon | Paris |

South Africa :

South Africa | Midrand |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Sr. Specialist, Quality Ecm

Job Description

Recommended Jobs

Sr. Cdm Programmer (Edc)

Sr. Cdm Programmer (Edc)

Sr. Medical Writer (Regulatory)

Sr. Medical Writer (Regulatory)

Sr. Director, Clinical Development (Md)- Inflammation/Fibrosis Therapeutic Area

Sr. Ep Field Clinical Specialist - Central/Western Us

Senior Site Contracts Specialist

Sr. Tmf Specialist

Sr. Tmf Specialist

Sr. Tmf Specialist

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Ireland

Pharma Jobs in China

Pharma Jobs in Netherland

Pharma Jobs in Australia

Pharma Jobs in United Kingdom

Pharma Jobs in England