Senior Executive

4-6 years

Not Disclosed

Remote

10 Feb. 11, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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: Senior Executive - Quality Assurance
Department: Quality Assurance
Location: Unit 2
Experience Required: 4-6 years
Educational Qualification: M.Pharm, M.Sc
Date Posted: 30-11-2023

Job Summary:

The Senior Executive in the Quality Assurance (QA) department plays a pivotal role in ensuring the continuous improvement and compliance of Quality Management System (QMS) practices. This includes performing GAP assessments, managing key QMS documents, and assisting in validation and qualification activities. The Senior Executive is also responsible for in-process quality checks and ensuring shop floor compliance.

Key Responsibilities:

GAP Assessment & QMS System Improvement:
- Perform GAP assessments for SOP versus current practices, identifying discrepancies.
- Identify gaps in the QMS system and ensure they are rectified as per the expectations outlined in EU annexures.
QMS Documentation Management:
- Oversee key QMS documents such as Change Control, Deviation, OOS (Out of Specification), CAPA (Corrective and Preventive Actions), incidents, APQR (Annual Product Quality Review), and investigations.
- Ensure timely closure and follow-up on these documents.
- Trend and track QMS documents for continuous improvement.
Online Document Review & Monitoring:
- Responsible for the review of online documents and ensuring compliance with relevant standards.
- Monitor dispensing of RM/PM, line clearance, IPQA (In-Process Quality Assurance) activity, and verification of status labels.
In-process Quality Assurance:
- Conduct In-process Quality Assurance checks for Quality Control (QC) and production teams.
- Follow up on corrective actions resulting from QA checks and audits.
Review of Product Documentation:
- Review in-process and finished product documentation, including Technical Data Sheets (TDS) and Certificates of Analysis (COA), ensuring accuracy and compliance.
Shop Floor Compliance:
- Ensure that the shop floor activities comply with the required quality standards and guidelines.
Qualification Activities:
- Handle qualification activities such as IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) in coordination with user departments and engineering teams.
Validation Assistance:
- Assist in validation activities at the manufacturing site, ensuring alignment with compliance requirements and industry best practices.
APQR Preparation & Review:
- Participate in the preparation and review of the Annual Product Quality Review (APQR), ensuring all required data is included and compliant.

Skills & Qualifications:

Educational Qualification:
- M.Pharm, M.Sc or a relevant field.
Experience:
- 4-6 years of experience in Quality Assurance, preferably in pharmaceutical or related industries.
Core Skills:
- GAP assessment for SOP vs. current practices.
- Strong knowledge of QMS systems and EU annexure expectations.
- Experience with key QMS documents (Change Control, Deviation, OOS, CAPA, APQR).
- Ability to trend and track QMS documents for process improvement.
- Familiarity with in-process checks, dispensing, line clearance, and verification of labels.
Additional Skills:
- Excellent attention to detail and problem-solving skills.
- Strong communication and interpersonal skills for collaborating across departments.
- Experience in qualification and validation activities (IQ, OQ, PQ).
- Familiarity with compliance and shop floor audits.

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh | Roorkee |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Boulder | Denver | Westminster |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Oeiras | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Knoxville | Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | OH | United States |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

Belgium :

Wavre |

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China | Quarry Bay |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Australia

Melbourne :

South Yarra |

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

North Brabant :

Breda |

South Holland :

Leiden |

Pharma Jobs in England

North Yorkshire :

Harrogate |

Oxfordshire :

Witney |

South Yorkshire :

Sheffield |

United Kingdom :

Pharma Jobs in United Kingdom

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Surrey :

Pirbright |

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

Buenos Aires :

Buenos Aires |

Austria :

Austria |

Vienna :

Vienna |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Flemish Brabant :

Zaventem |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Lyon | Paris |

Attica :

Koropi | Athens |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan | Saitama |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

North Island :

Auckland |

Lima Region :

Lima |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

Midrand | South Africa |

Brazil :

Brazil | Sao paulo |

South America :

Peru | Argentina |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |

Senior Executive

Job Description

Job Summary:

Key Responsibilities:

Skills & Qualifications:

Latest Jobs

Senior Cra

Quality Control Lab Technician

Associate Dean Of Clinical Affairs - Hs Associate / Full Clinical Professor

Associate Director, Global Pv Operations - Job Id: Gpv

Representative, Operations

Clinical Data Manager

Global Leader - Mlr Services

Lead - Business Analyst

Associate Manager - Regulatory Solutions

Lead - Regulatory Solutions