Quality Assurance

1 week ago

Ankleshwar, India Zentiva Group, a.s. Full time

Assistant Manager - Regulatory Affairs

You will have the opportunity to:

- Ensure compliance with regulatory requirements and support successful registration and approval of manufactured products
- Preparation of high quality documents for Drug Product and Drug Substance as part of Product Life cycle management, New MAA, Response to HA Queries
- Management of Regulatory changes - Change Initiation, evaluation and GxP compliance
- To evaluate impact of CMC changes on registration file and to prepare and manage technical packages for different types of variations as per European variation guideline.
- To work in collaboration with Global Regulatory affairs, Global Quality, Zentiva Affiliates, Site Strategy, Supply Chain, EXIM, Production operations, Quality Assurance, Quality Control and site services to ensure timely implementation of Regulatory actions associated with Industrial projects and business priorities
- Review of GxP documents, Artworks & Labelling against registered Product Dossiers to ensure regulatory compliance
- Preparation of CMC Dossiers / Administrative documents / Response to Health Authorities viz. Module 1, Module 2 - Quality Overall Summary & Module 3 etc for products which are manufactured at Ankleshwar site and registered worldwide
- Liaising and negotiating with regulatory authorities
- Knowledge management, impart Training to Zentiva associates on Regulatory Requirements and cGMP topics.
- Other responsibilities as assigned

You will love this role/ team because:

- Excellent working environment and a passionate team of professionals;
- Continuous Learning & Development opportunities

You will strive in this role if you have:

- M. Pharm / B. Pharm with 5 to 8 years’ of experience in Pharmaceutical Industry
- Knowledge of Chemistry, Manufacturing and Controls (CMC) & Quality Management System for Pharmaceutical Formulations, Active Pharmaceutical Ingredients, D&C Act, EUDRALEX - EU Legislation, GMP requirements
- Good written and verbal communication skills, analytical skills so as to collaborate independently with Global RA / liaison with Drug Regulatory Authorities
- Motivation to travel for HA Interactions
- Ability to learn / quick adaptability / analytical /organized / communicative
- To follow requirements of solid line manager and job description.
- To follow tasks and timelines, set for particular activities and projects.
- To work independently, to be proactive

To learn more about our D&I commitment,

click here


Join our winning team Be a part of our winning culture Be Zentiva

  • Quality Assurance Officer

    2 months ago

    Ankleshwar, India Jigar Industries Full time

    Preparing and implementing quality assurance policies and procedures. - Identifying and resolving workflow and production issues. - Ensuring that standards and safety regulations are observed. - Addressing and discussing issues and proposed solutions with superiors. - Documenting quality assurance activities and creating audit reports. - Making...

  • Officer - Quality Assurance

    3 weeks ago

    Ankleshwar, India Kaapro Management Solutions Full time

    Opening: 2 Nos.- Job ID: 56491- Employment Type: Full Time- Reference: - Work Experience: 2.0 Year(s) To 7.0 Year(s)- CTC Salary: 3.00 LPA TO 7.00 LPA- Function: Production / Quality / Maintenance- Industry: Pharma/Biotech/Clinical Research- Qualification: B.Pharma - Pharmacy; B.Sc - Chemistry; M.Pharma - Pharmacy; M.Sc / MS Science - Chemistry- Location: -...

  • Officer - Quality Assurance

    2 weeks ago

    ankleshwar, India Paradise Placement Consultancy Full time

    Job Description: REQUIREMENTS Education / Experience Education: Graduate / Post Graduate in Pharmacy or Chemistry Experience: 2-3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements JOB PURPOSE Generic ...

  • Officer - Quality Assurance

    2 months ago

    ankleshwar, India Paradise Placement Consultancy Full time

    Job Description: REQUIREMENTS Education / Experience Education: Graduate / Post Graduate in Pharmacy or Chemistry Experience: 2-3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements JOB PURPOSE Generic ...

  • Executive - Quality Assurance Pharma

    4 weeks ago

    Ankleshwar, India Zentiva Group, a.s. Full time

    Job Description for Executive - Quality Assurance, Pharma Educational Qualification - B. Pharm / M. Pharm from a reputed university Experience - 2 to 5 years of similar experience in regulatory-approved OSD manufacturing large units. Documentation Control: Preparation and Review of SOPs Controlled distribution and archival of documents & records Control...

  • Executive - Quality Assurance, Pharma

    2 months ago

    Ankleshwar, India Zentiva Group, a.s. Full time

    Job Description for Executive - Quality Assurance, Pharma Educational Qualification - B. Pharm / M. Pharm from reputed university Experience - 3 to 5 years similar experience in regulatory approved OSD manufacturing large unit. Quality Management/Continuous Improvement Line Clearance and shop floor compliance Assisting in Complaint Investigation system...

  • Officer - Quality Assurance

    1 week ago

    Ankleshwar, India Paradise Placement Consultancy Full time

    Job Description:REQUIREMENTSEducation / ExperienceEducation:Graduate / Post Graduate in Pharmacy or ChemistryExperience:2-3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirementsJOB PURPOSEGenericImplement Quality Assurance activities for Pharmaceutical at...

  • Officer - Quality Assurance

    4 days ago

    Ankleshwar, Gujarat, India Kaapro Management Solutions Full time

    Opening: 2 Nos Job ID:Employment Type:Full Time- Reference:Work Experience: 2.0 Year(s)To 7.0 Year(s)- CTC Salary: 3.00 LPA TO 7.00 LPA- Function: Production / Quality / Maintenance- Industry: Pharma/Biotech/Clinical Research- Qualification: B.Pharma - Pharmacy; B.Sc - Chemistry; M.Pharma - Pharmacy; M.Sc / MS Science - Chemistry- Location: AnkleshwarPosted...

  • Officer - Quality Assurance

    4 days ago

    Ankleshwar, Gujarat, India Paradise Placement Consultancy Full time

    Job Description:REQUIREMENTSEducation / ExperienceEducation:Graduate / Post Graduate in Pharmacy or ChemistryExperience:2-3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirementsJOB PURPOSEGenericImplement Quality Assurance activities for Pharmaceutical at...

  • Quality Assurance Executive

    2 months ago

    Ankleshwar, India SV Placement Full time

    3 - 4 years - Ankleshwar, Gujarat - 4-5 Lacs P.A. - 9 minutes agoAPPLY **Role & Responsibilities**: - Implement and maintain the companys quality assurance policies and procedures to ensure compliance with regulatory standards, including FDA, EMA, and other relevant regulations - Develop and oversee quality control processes for raw materials,...

  • Quality Assurance Executive

    2 days ago

    Ankleshwar, India SV Placement Full time

    3 - 4 years - Ankleshwar, Gujarat - 4-5 Lacs P.A. - 9 minutes agoAPPLY **Role & Responsibilities**: - Implement and maintain the companys quality assurance policies and procedures to ensure compliance with regulatory standards, including FDA, EMA, and other relevant regulations - Develop and oversee quality control processes for raw materials,...

  • Executive - Quality Assurance, Pharma

    2 months ago

    Ankleshwar, India Zentiva Group, a.s. Full time

    Job Description for Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from reputed university Experience 3 to 5 years similar experience in regulatory approved OSD manufacturing large unit. Quality Management/Continuous Improvement Line Clearance and shop floor compliance Assisting in Complaint...

  • Executive - Quality Assurance, Pharma

    2 months ago

    ankleshwar, India Zentiva Group, a.s. Full time

    Job Description for Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from reputed university Experience 3 to 5 years similar experience in regulatory approved OSD manufacturing large unit. Quality Management/Continuous Improvement Line Clearance and shop floor compliance Assisting in...

  • Executive - Quality Assurance, Pharma

    4 days ago

    Ankleshwar, Gujarat, India Zentiva Group, a.s. Full time

    Job Description for Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from reputed university Experience 3 to 5 years similar experience in regulatory approved OSD manufacturing large unit. Quality Management/Continuous Improvement Line Clearance and shop floor compliance Assisting in Complaint...

  • Officer, Quality Assurance

    3 days ago

    Ankleshwar, Gujarat, India Zentiva Group, a.s. Full time

    Education:Graduate / Post Graduate in Pharmacy or ChemistryExperience:0 - 3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirementsQuality Management/Continuous ImprovementLine Clearance and shop floor complianceAssisting in Complaint Investigation system at...

  • Executive - Quality Assurance Pharma

    4 weeks ago

    Ankleshwar, India Zentiva Group, a.s. Full time

    Job Description for Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 2 to 5 years of similar experience in regulatory-approved OSD manufacturing large units. Documentation Control: Preparation and Review of SOPs Controlled distribution and archival of documents...

  • Executive - Quality Assurance Pharma

    3 weeks ago

    Ankleshwar, India Zentiva Group, a.s. Full time

    Job Description for Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 2 to 5 years of similar experience in regulatory-approved OSD manufacturing large units. Documentation Control: Preparation and Review of SOPs Controlled distribution and archival of documents...

  • Executive - Quality Assurance Pharma

    3 days ago

    Ankleshwar, Gujarat, India Zentiva Group, a.s. Full time

    Job Description for Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 2 to 5 years of similar experience in regulatory-approved OSD manufacturing large units. Documentation Control: Preparation and Review of SOPs Controlled distribution and archival of...

  • Executive - Quality Assurance Pharma

    2 weeks ago

    ankleshwar, India Zentiva Group, a.s. Full time

    Job Description for Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 2 to 5 years of similar experience in regulatory-approved OSD manufacturing large units. Documentation Control: Preparation and Review of SOPs Controlled distribution and...

  • Executive - Quality Assurance Pharma

    4 weeks ago

    ankleshwar, India Zentiva Group, a.s. Full time

    Job Description for Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 2 to 5 years of similar experience in regulatory-approved OSD manufacturing large units. Documentation Control: Preparation and Review of SOPs Controlled distribution and...