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View All Corrective Actions Jobs View All Jobs in Ankleshwar

4 Corrective Actions jobs in Ankleshwar

Executive - Quality Control, Pharma

New
Ankleshwar, Gujarat Zentiva Group, a.s.

Posted today

Job Viewed

Tap Again To Close

Job Description

Position Title: Executive – Quality Control  

Qualification and Experience:

M. Sc (Organic / Analytical Chemistry) / B. Pharm with 2 - 6 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge

Job overview:

  • Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements.

    • Responsibilities:

  • Analysis:

    • Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples.

    Performing analysis of Stability, process validation samples, and Cleaning Validation.

    Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc.

  • Good Laboratory Practice

    • Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment.

    Knowledge on the preparation of SOPs and Formats and Analytical Test records.

    Managing reference standards, working standards, laboratory reagents & chemicals.

    Arranging and observing Control Samples and maintaining the record.

    Participating in the Investigation of out-of-specification results.

    Maintaining laboratory raw data related to testing activity.

  • Validation

    • Performing Analytical Method validation, cleaning validation as per the protocol.

  • Other

    • Coordinating with production and the warehouse for analytical activities

    Compliance to HSE Requirements for QC laboratory.

    Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations.

    Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities.

    Requirements

  • GMP & GLP knowledge
  • Good coordination & communication skills.
  • Analytical ability
  • Knowledge on LIMS & QMS

    • What makes this position unique?

  • This position will provide good exposure to work in GMP/ GLP environment.

    • Location information: Ankleshwar, Gujarat, India

    This advertiser has chosen not to accept applicants from your region.

    Executive - Quality Control, Pharma

    Ankleshwar, Gujarat Zentiva Group, a.s.

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    Position Title: Executive – Quality Control  

    Qualification and Experience:

    M. Sc (Organic / Analytical Chemistry) / B. Pharm with 2 - 6 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge

    Job overview:

  • Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements.

    • Responsibilities:

  • Analysis:

    • Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples.

    Performing analysis of Stability, process validation samples, and Cleaning Validation.

    Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc.

  • Good Laboratory Practice

    • Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment.

    Knowledge on the preparation of SOPs and Formats and Analytical Test records.

    Managing reference standards, working standards, laboratory reagents & chemicals.

    Arranging and observing Control Samples and maintaining the record.

    Participating in the Investigation of out-of-specification results.

    Maintaining laboratory raw data related to testing activity.

  • Validation

    • Performing Analytical Method validation, cleaning validation as per the protocol.

  • Other

    • Coordinating with production and the warehouse for analytical activities

    Compliance to HSE Requirements for QC laboratory.

    Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations.

    Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities.

    Requirements

  • GMP & GLP knowledge
  • Good coordination & communication skills.
  • Analytical ability
  • Knowledge on LIMS & QMS

    • What makes this position unique?

  • This position will provide good exposure to work in GMP/ GLP environment.

    • Location information: Ankleshwar, Gujarat, India

    This advertiser has chosen not to accept applicants from your region.

    Manager / Sr. Manager - Quality Control

    Ankleshwar, Gujarat Zentiva Group, a.s.

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    Job Title : Manager / Sr. Manager, Quality Control.

    Qualification: Post Graduate in Science (Organic or Analytical Chemistry ) with 12 to 15 years of experience.

    Job Summary :

    Plan and implement Quality Control activity adhering to Zentiva Quality Guidelines, local FDA regulations, and HSE guidelines, leading a team of subordinates with optimum utilization of resources in order to ensure consistent good quality of products to meet with the GMP standards and customers’ requirements, living the Group’s Values and Code of Ethics. Strong leadership

  • Analytical ability
  • Interpreting skills
  • Leadership
  • Knowledge of cGLP & Regulatory Guidelines
  • Modern QC instrumentation Techniques
  • Communication
  • Interpersonal Relationship Excellent problem-solving, decision-making, and organizational skills.

    • KEY ACCOUNTABILITIES

    Quality

  • Design & Implementation of cGLP for Pharmaceutical laboratory ensuring compliance with Global Quality guidelines, local FDA (Schedule M & L) and other regulatory requirements of importing countries and Zentiva Quality standard.
  • Ensure analytical method validation and transfer. Responsible for review and approval of SOPs, recording formats, test methods - specification, validation protocol / report, qualification and calibration of record of laboratory equipment, OOS/OOT/deviation investigation and re-analysis/fresh analysis decision, management of reference standards, Retained sample Management and training on GLP.
  • Ensure the maintenance of laboratory premises and equipment.
  • Manage Pharmaceutical laboratory activities by organizing / planning of sampling, testing, Qualification, Validation, Calibration, maintenance and related documentation.
  • Participate in failure investigation, to carry out root cause analysis of failure /market complaints if any. Maintain change control, deviation & CAPA system.
  • Responsible for reviewing the testing raw data, log book and related documents.

    • Testing

  • Organize and ensure timely sampling and testing of Chemical, Microbiological and Physical analysis of RM/PM, intermediates, finished goods and other samples for Pharmaceuticals. Also ensure timely analysis of stability samples, market complaints, process validation, cleaning validation and environmental monitoring samples.
  • Ensure the monitoring of the stability of the products & stability section.
  • Approval / Rejection of Raw Materials, Packaging Components and in process material.
  • Extend testing support for Microbial testing & stability sample management of API / PD products / intermediates.
  • Out Of Specification/ Out Of Trend Results investigations.
  • Organize trending of QC analytical data as a part of Statistical Quality Control.
  • To approve and monitor any contract laboratory.
  • Organizing calibration / maintenance / qualification of laboratory Equipment and laboratory area.
  • Organize collection and storage of Retention samples.

    • HSE / IMS / GMP / GLP

  • Implement the HSE and GMP norms, adherence to compliance, training and corrective actions in order to ensure that there is no deviation from the Zentiva standards and statutory HSE and GMP / GLP norms.
  • Implement the system of working established as per IMS / ISO requirements in the Quality Operations department.
  • Organizing and maintaining the health, safety and environmental management system.
  • Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
  • Reviewing pharmacopeias and change control evaluation.

    • Compliance

  • Ensure compliance with FDA regulations; interact with local and State FDA authorities for Pharmaceuticals function requirements.
  • Performing internal quality audit as well as third party GMP audit as a “Qualified Auditor” during Quality Audit abiding the audit schedule.

    • Training, People Management, and Industrial Relations

  • Train team members for laboratory-related jobs and evaluate for individual development.
  • Monitoring good industrial relations in the department.

    • Coordination

  • Coordinate with purchase, warehouse, and production for planning and for vendor evaluation & development, for Technical Agreement Evaluation, Supplier Testing Approval, Audits of supplier- Contract Labs. Preparation and submission of laboratory documents for registration, for technical and liaison support respectively.

    • Other

  • Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
  • Organizing and planning requirements for laboratory consumables and monitoring the stock of chemical, glassware, standards, and other related items.
    • This advertiser has chosen not to accept applicants from your region.

    Manager / Sr. Manager - Quality Control

    Ankleshwar, Gujarat Zentiva Group, a.s.

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    Job Title : Manager / Sr. Manager, Quality Control.

    Qualification: Post Graduate in Science (Organic or Analytical Chemistry ) with 12 to 15 years of experience.

    Job Summary :

    Plan and implement Quality Control activity adhering to Zentiva Quality Guidelines, local FDA regulations, and HSE guidelines, leading a team of subordinates with optimum utilization of resources in order to ensure consistent good quality of products to meet with the GMP standards and customers’ requirements, living the Group’s Values and Code of Ethics. Strong leadership

  • Analytical ability
  • Interpreting skills
  • Leadership
  • Knowledge of cGLP & Regulatory Guidelines
  • Modern QC instrumentation Techniques
  • Communication
  • Interpersonal Relationship Excellent problem-solving, decision-making, and organizational skills.

    • KEY ACCOUNTABILITIES

    Quality

  • Design & Implementation of cGLP for Pharmaceutical laboratory ensuring compliance with Global Quality guidelines, local FDA (Schedule M & L) and other regulatory requirements of importing countries and Zentiva Quality standard.
  • Ensure analytical method validation and transfer. Responsible for review and approval of SOPs, recording formats, test methods - specification, validation protocol / report, qualification and calibration of record of laboratory equipment, OOS/OOT/deviation investigation and re-analysis/fresh analysis decision, management of reference standards, Retained sample Management and training on GLP.
  • Ensure the maintenance of laboratory premises and equipment.
  • Manage Pharmaceutical laboratory activities by organizing / planning of sampling, testing, Qualification, Validation, Calibration, maintenance and related documentation.
  • Participate in failure investigation, to carry out root cause analysis of failure /market complaints if any. Maintain change control, deviation & CAPA system.
  • Responsible for reviewing the testing raw data, log book and related documents.

    • Testing

  • Organize and ensure timely sampling and testing of Chemical, Microbiological and Physical analysis of RM/PM, intermediates, finished goods and other samples for Pharmaceuticals. Also ensure timely analysis of stability samples, market complaints, process validation, cleaning validation and environmental monitoring samples.
  • Ensure the monitoring of the stability of the products & stability section.
  • Approval / Rejection of Raw Materials, Packaging Components and in process material.
  • Extend testing support for Microbial testing & stability sample management of API / PD products / intermediates.
  • Out Of Specification/ Out Of Trend Results investigations.
  • Organize trending of QC analytical data as a part of Statistical Quality Control.
  • To approve and monitor any contract laboratory.
  • Organizing calibration / maintenance / qualification of laboratory Equipment and laboratory area.
  • Organize collection and storage of Retention samples.

    • HSE / IMS / GMP / GLP

  • Implement the HSE and GMP norms, adherence to compliance, training and corrective actions in order to ensure that there is no deviation from the Zentiva standards and statutory HSE and GMP / GLP norms.
  • Implement the system of working established as per IMS / ISO requirements in the Quality Operations department.
  • Organizing and maintaining the health, safety and environmental management system.
  • Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
  • Reviewing pharmacopeias and change control evaluation.

    • Compliance

  • Ensure compliance with FDA regulations; interact with local and State FDA authorities for Pharmaceuticals function requirements.
  • Performing internal quality audit as well as third party GMP audit as a “Qualified Auditor” during Quality Audit abiding the audit schedule.

    • Training, People Management, and Industrial Relations

  • Train team members for laboratory-related jobs and evaluate for individual development.
  • Monitoring good industrial relations in the department.

    • Coordination

  • Coordinate with purchase, warehouse, and production for planning and for vendor evaluation & development, for Technical Agreement Evaluation, Supplier Testing Approval, Audits of supplier- Contract Labs. Preparation and submission of laboratory documents for registration, for technical and liaison support respectively.

    • Other

  • Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
  • Organizing and planning requirements for laboratory consumables and monitoring the stock of chemical, glassware, standards, and other related items.
    • This advertiser has chosen not to accept applicants from your region.
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    Nearby Locations

    Other Jobs Near Me

    Industry

    1. request_quote Accounting
    2. work Administrative
    3. eco Agriculture Forestry
    4. smart_toy AI & Emerging Technologies
    5. school Apprenticeships & Trainee
    6. apartment Architecture
    7. palette Arts & Entertainment
    8. directions_car Automotive
    9. flight_takeoff Aviation
    10. account_balance Banking & Finance
    11. local_florist Beauty & Wellness
    12. restaurant Catering
    13. volunteer_activism Charity & Voluntary
    14. science Chemical Engineering
    15. child_friendly Childcare
    16. foundation Civil Engineering
    17. clean_hands Cleaning & Sanitation
    18. diversity_3 Community & Social Care
    19. construction Construction
    20. brush Creative & Digital
    21. currency_bitcoin Crypto & Blockchain
    22. support_agent Customer Service & Helpdesk
    23. medical_services Dental
    24. medical_services Driving & Transport
    25. medical_services E Commerce & Social Media
    26. school Education & Teaching
    27. electrical_services Electrical Engineering
    28. bolt Energy
    29. local_mall Fmcg
    30. gavel Government & Non Profit
    31. emoji_events Graduate
    32. health_and_safety Healthcare
    33. beach_access Hospitality & Tourism
    34. groups Human Resources
    35. precision_manufacturing Industrial Engineering
    36. security Information Security
    37. handyman Installation & Maintenance
    38. policy Insurance
    39. code IT & Software
    40. gavel Legal
    41. sports_soccer Leisure & Sports
    42. inventory_2 Logistics & Warehousing
    43. supervisor_account Management
    44. supervisor_account Management Consultancy
    45. supervisor_account Manufacturing & Production
    46. campaign Marketing
    47. build Mechanical Engineering
    48. perm_media Media & PR
    49. local_hospital Medical
    50. local_hospital Military & Public Safety
    51. local_hospital Mining
    52. medical_services Nursing
    53. local_gas_station Oil & Gas
    54. biotech Pharmaceutical
    55. checklist_rtl Project Management
    56. shopping_bag Purchasing
    57. home_work Real Estate
    58. person_search Recruitment Consultancy
    59. store Retail
    60. point_of_sale Sales
    61. science Scientific Research & Development
    62. wifi Telecoms
    63. psychology Therapy
    64. pets Veterinary
    View All Corrective Actions Jobs View All Jobs in Ankleshwar
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