drjobs Junior Manager-APIPL-AAR AP

Junior Manager-APIPL-AAR AP

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1 Vacancy
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Job Location drjobs

Bengaluru - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Apotex Pharmachem India Pvt Ltd. is bulk drug Pharmaceutical Company situated in the Bommasandra Industrial Area in Bangalore. It is mainly into R & D activities of APIs or Active Pharmaceutical Ingredients along with support activities like Quality Assurance Quality Control and Analytical Services. Its parent company is situated in Canada. It is certified as Great Place to Work for the year 2017-18 from an Institute of Grate Place to work

Job Summary

  • To ensure analytical and research activities with current regulatory needs.
  • To build analytical capacity within the department to ensure compliance and adherence to the standard operating procedure. Support to the cross functional department to enhance collaboration and business needs.
  • Toensure and adhere to Apotex quality values in order to make quality pharmaceuticals.

Job Responsibilities

  • Validation of analytical methods for drug substance intermediates and raw materials.
  • Preparation of validation protocol for drug substance intermediates and raw materials.
  • Preparation of validation summary report for validated analytical methods and online documentation of analysis in laboratory notebook
  • Cleaning method development and validation by HPLC & UV (Rinse and Swab method).
  • Additional Test request analysis.
  • Analytical support for the routine anlysis of impurities raw materials intermedietes and drug substances.
  • Anatical support for the Standard certification of impuritiesraw materialsintermediates and drug substance.
  • Performing protocol based method transfer activities of analytical methods for drug substance intermediates and raw materials.
  • Preparation of Internal Method Transfer protocol for drug substance intermediates and raw materials.
  • Preparation/Review of SOPs relevant to AD department.
  • Preparation/Review of method of analysis.
  • Initiation of Change control through Trackwise related to AD.
  • Upkeep of Laboratory cleanliness safety and Good Laboratory Practices (GLP).
  • To adhere the EHS policy & procedure in routine activities.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Demonstrate Behaviours that exhibit our organizational Values: Collaboration Courage Perseverance and Passion.
  • Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program Global Quality policies and procedures Safety and Environment policies and HR policies.

Job Requirements

Education

  • Minimum Masters degree in science / pharmacy.

Knowledge Skills and Abilities

  • Handling of Empower software
  • Handling of Tiamo 2.5 multi software
  • Handling of Spectrum1 Software
  • Handling of Chemstation software
  • Handling of Trackwise
  • Highly Responsible organized self-motivated with excellent analytical aptitude Good Communication project management skills and Personality development virtues.

Experience

  • 6 years of experience in Analytical Research & development.


Apotex Pharmachem India Pvt Ltd. is bulk drug Pharmaceutical Company situated in the Bommasandra Industrial Area in Bangalore. It is mainly into R & D activities of APIs or Active Pharmaceutical Ingredients along with support activities like Quality Assurance Quality Control and Analytical Services. Its parent company is situated in Canada. It is certified as Great Place to Work for the year 2017-18 from an Institute of Grate Place to work


Required Experience:

Manager

Employment Type

Full Time

Company Industry

About Company

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