Quality Alert Expert

15 hours ago

Ankleshwar, Gujarat, India Zentiva Full time ₹ 20,00,000 - ₹ 25,00,000 per year

JOB DESCRIPTION

Position: Quality Alert Expert

MANDATORY REQUIREMENTS

  • Graduated / Post-graduate in Pharmacy/Medicine or Chemistry
  • 10 to 12 years minimum experience in Quality or Regulatory Affairs
  • Experience obtained in pharmaceutical manufacturing sites (+5 years).
  • Skilled in the usage of IT tools (for example: Trackwise, Share/DrugTrack, eDMS), .
  • English speaker
  • Good organizational skills, stress resistance, and flexibility
  • Good Team player and good at decision-making
  • Experience in the pharmaceutical industry with a good level of GxP know-how is a strong plus.
  • Reactivity, autonomy with a sense of urgency and priorities.
  • Open-mindedness and team spirit.

Position Location:

  • Ankleshwar, Zentiva Pvt Ltd, Gujarat, India

ROLE SPECIFICATIONS

  • Role: Quality Expert Alert
  • Department: Quality Assurance
  • Reports to: Corporate Escalation & Regulatory Surveillance Manager

PURPOSE OF THE ROLE

  • To act as quality coordinator for quality alerts investigation and further communication
  • To act as an industrial quality focal point for quality defects and troubleshooting
  • To act as a member of the team for the project "Nitrosamine in human medicines" to ensure the Authorities' requests and business continuity

MAIN RESPONSIBILITIES & Accountabilities

  • End-to-end coordination of quality alert issues/investigation with Zentiva production sites, CMO, and affiliates
  • Operational management of the quality alerts in the Zentiva QMS system (Quality Forward)
  • Coordination of investigation reports compilation, risk confirmation, and countries notification, participation in Risk meetings
  • Regular check of the authorities' websites regarding new quality alerts detection and their impact on company entities
  • Supervising the timely execution of quality alerts in scope
  • Support Quality Alerts, Risk Management, and Country Quality-related tasks based on the manager's instructions
  • Providing a coordination role for the project "Nitrosamines in human medicines", work with the nitrosamine database
  • Providing regular reporting in respective areas
  • The employee will perform other tasks under the direction of the Manager within the agreed type of work.

OTHER RESPONSIBILITIES

QUALITY

Comply with the principles of cGxPs and Zentiva's Quality Standards in carrying out the activities of competence and regularly participate in the related training.

HSE

Comply with the principles communicated within the framework of the Zentiva ESMS Policy, specified in the Company's internal regulations for the purpose of compliance with Occupational Health and Safety regulations and the Environment and Safety Management System.

VIGILANCE

Report adverse events and any other safety information related to ZENTIVA medicines, medical devices, cosmetics, and dietary supplements online in the manner provided for in internal procedures.

COMPLIANCE

Observe the Company's rules and policies. Fully adhere to the principles set out in the Code of Ethics.

SUSTAINABILITY

Adhere to the ESG principles detailed as part of Zentiva's Sustainability Strategy, which is divided into 3 pillars: People, Partners, Planet.

  • Quality Alert Expert

    2 days ago

    Ankleshwar, Gujarat, India Zentiva Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    JOB DESCRIPTIONPosition: Quality Alert Expert  MANDATORY REQUIREMENTS Graduated / Post-graduate in Pharmacy/Medicine or Chemistry10 to 12 years minimum experience in Quality or Regulatory AffairsExperience obtained in pharmaceutical manufacturing sites (+5 years).Skilled in the usage of IT tools (for example: Trackwise, Share/DrugTrack, eDMS), .English...

  • Human Resources Manager

    6 days ago

    Ankleshwar, Gujarat, India Farbe Firma Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionFarbe Firma Pvt. Ltd. is a leading pharmaceutical company specializing in injectables and critical care products. We develop cutting-edge medicines tailored to meet the needs of our customers. Our commitment to quality care drives our investment in research and development. Our expert team has extensive pharmaceutical industry knowledge...

  • Instrumentation Engineer

    1 week ago

    Ankleshwar, Gujarat, India Finorchem Limited Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    He will also be responsible for maintenance & scheduling of PM plan for the entire plant instrument items.He must be Domain Expert w.r.t Instrumentation as mentioned below.· Advanced process control (APC)· Distributed control systems (DCS)· Programmable logic controllers (PLC)· Supervisory control and data acquisition (SCADA)· IMCC's & its trouble...

  • Plant Manager

    6 days ago

    Ankleshwar, Gujarat, India Solenis Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Business : Supply ChainJob Title : Plant ManagerLocation:AnkleshwarAbout SolenisSolenis is a leading global producer of specialty chemicals focused on partnering with water-intensive operations to solve complex water treatment, process improvement and hygiene challenges with advanced chemical and equipment solutions for consumer, industrial, institutional,...

  • Plant Manager

    6 days ago

    Ankleshwar, Gujarat, India Solenis Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Business : Supply ChainJob Title : Plant ManagerLocation: Ankleshwar ABOUT SOLENISSolenis is a leading global producer of specialty chemicals focused on partnering with water-intensive operations to solve complex water treatment, process improvement and hygiene challenges with advanced chemical and equipment solutions for consumer, industrial,...

  • Quality Alert Expert

    2 weeks ago

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

    JOB DESCRIPTION Position: Quality Alert Expert MANDATORY REQUIREMENTS Graduated / Post-graduate in Pharmacy/Medicine or Chemistry 10 to 12 years minimum experience in Quality or Regulatory Affairs Experience obtained in pharmaceutical manufacturing sites (+5 years). Skilled in the usage of IT tools (for example: Trackwise, Share/DrugTrack, eDMS), ....

  • [15h Left] Quality Alert Expert

    3 weeks ago

    Ankleshwar, GJ, IN Zentiva Full time

    JOB DESCRIPTION Position Quality Alert Expert MANDATORY REQUIREMENTSGraduated Post-graduate in Pharmacy Medicine or Chemistry 10 to 12 years minimum experience in Quality or Regulatory Affairs Experience obtained in pharmaceutical manufacturing sites 5 years Skilled in the usage of IT tools for example Trackwise Share DrugTrack eDMS ...

  • Quality Alert Expert

    1 week ago

    Ankleshwar, India Zentiva Full time

    Job Description Job Description Position: Quality Alert Expert Mandatory Requirements - Graduated / Post-graduate in Pharmacy/Medicine or Chemistry - 10 to 12 years minimum experience in Quality or Regulatory Affairs - Experience obtained in pharmaceutical manufacturing sites (+5 years). - Skilled in the usage of IT tools (for example: Trackwise,...

  • Supervisor / Plant Operator

    2 weeks ago

    Ankleshwar, India Shivaanya Talent Solutions Full time

    Ankleshwar, Gujarat, India - Permanent - Quality Assurance - 2 - 6 years About us Job Title: Supervisor / Plant Operator **Job Description**: - | Supervise and execute daily production activity as per micro plan and check make shift wise production. If production is not achieved as per plant capacity due to break down and inform to Engineering Dept &...

  • Assistant Production Manager

    2 weeks ago

    Ankleshwar, India Disha Skill Training Services Full time

    Job Title: Assistant Manager Production- Biotech Job Location : Dahej This vacancy is for our Client who is manufacturing Surfactants and Speciality Chemical. Role And Responsibility 1. Successfully led the development, scale-up and fermentation production of microbial products. 2. Run a fermentation-based manufacturing plant with maximum productivity...

  • Sap Deo

    3 weeks ago

    Ankleshwar, GJ, IN Galiakotwala Engineering Company pt. ltd Full time

    Responsibility Through Knowledge of SAP System Operation Getting Various Reports from SAP Expert in SAP Entries Expert in Making Purchase Requisitions Purchase Order Service Order To Make Delivery Challan Invoice E-way Bills etc Skills Required Good knowledge of SAP for Entry of purchase Account department like Po Petty Cash ...

  • Plant Manager

    5 days ago

    Ankleshwar, India Solenis Full time

    Job Description Business : Supply Chain Job Title : Plant Manager Location: Ankleshwar About Solenis Solenis is a leading global producer of specialty chemicals focused on partnering with water-intensive operations to solve complex water treatment, process improvement and hygiene challenges with advanced chemical and equipment solutions for consumer,...

  • Plant Manager

    4 days ago

    Ankleshwar, GJ, IN Solenis Full time

    Business Supply Chain Job Title Plant Manager Location Ankleshwar ABOUT SOLENIS Solenis is a leading global producer of specialty chemicals focused on partnering with water-intensive operations to solve complex water treatment process improvement and hygiene challenges with advanced chemical and equipment solutions for consumer industrial institutional food...