Monday, January 30, 2023

PAREXEL is looking for RA, Principal Biostatistician, Statistical Programmer || Apply here

Excellent opportunity to join one of the best employee friendly company. PAREXEL is looking for the following positions with EXPERIENCE.

Senior Regulatory Affairs Associate, Regulatory Affairs Associate, Senior Regulatory Affairs Consultant at Bengaluru/ Hyderabad/ Homebased. Principal Biostatistician, Senior Biostatistician, Principal Statistical Programmer, Senior Statistical Programmer, Statistical Programmer II, - Any locations.

Associate Manager, Data Management, Senior Clinical Data Analyst, Associate Director - Epidemiologist - Home based.
Associate Director, Health Economics - India- Bengaluru/ Hyderabad/Mohali/ Chandigarh/ Homebased.

If you're interested and looking for a change, kindly send your latest CV to Prathap.vedhavyasamurthy@parexel.com, Shameer.Parambil@parexel.com.

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Encube Ethicals Pvt Ltd is hiring for Quality Assurance Department for Mumbai location

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We at Encube Ethicals are hiring for Quality Assurance Department.

Department : QA.
Qualification : M Pharma/M Sc.
Experience : 4-8 Years
Location : Andheri (Marol), Mumbai.

Roles and Responsibilities:-

  • Review of analytical data, analytical method validation, method transfer protocol and reports.
  • Handling QMS (Deviation and CAPA) and OOS related activities.
  • Preparation, review and revision of QA procedures.
  • Review and approval of STP and specification.
  • Preparation, review of annual reports and any other reports assigned by the reporting manager.

Interested candidate can share their CV's on prashant.kshirsagar@encubeethicals.com


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Sunday, January 29, 2023

Encube Ethicals Pvt Ltd hiring for Production and Quality control department || Apply here

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BioGenomics Ltd hiring for Formulation department as a principal scientist || Apply now

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Company: BioGenomics Ltd

Department: Formulation

Post: principal scientist

Location: Thane


Requirements

  • Master's in microbiology/Life science
  • Experience of working with Insulin analogs
  • Total Experience- 8 - 12 years


Key Responsibility areas

  • Developing New formulations for protein therapeutics such as Insulin & Insulin analogs & improving the existing formulations
  • Carrying out Stability Studies
  • Analytical Method Development & Tech Transfer to Manufacturing Plant
  • Characterization of Drug Product. \
  • Preparing for various Audits, ensuring compliance & actively participating in conducting the audits. Support the formulation fill finish & product release requirements from Manufacturing.
  • Lead the department to ensure that all internal and external customer expectations are met and department objectives are achieved.
  • Report performance of team and individual members and organize necessary interventions for improvement.


Technical Competencies

  • Pre-formulation & Formulation Method development & Validation for products such as Insulin & Insulin Analogs
  • Knowledge of Chemistry & Analytical instruments like HPLC, LCMS and Bioassay Methods.
  • Product Specific knowledge
  • Thorough understanding of Regulatory Affairs, IPR & different guidelines like ICH (Schedule O, S, E & M), EMEA, FDA, Central Drugs Standard Control Organization (CDSCO).
  • Exposure to Manufacturing of Protein Therapeutics.


Please share your resumes on Careers@biogenomics.co.in


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Hetero drugs ltd hiring "SENIOR MANAGER/AGM/DGM" for Quality Control Department || Apply here

Greetings from Hetero....!

we are hiring "SENIOR MANAGER/AGM/DGM" for Quality Control Department

Note : Applicants must be from Api Manufacturing Company's (Regulatory Companies)

Work Location: Nakkapalli ( Tuni)
Department: Quality Control
Designation: SENIOR MANAGER/AGM/DGM
Qualification : B Pharmacy/M.SC Chemistry
Experience: 15 - 20 years
CTC: Best in Industry

  • Applicants must have good knowledge in all functions of Quality Control.
  • Must have Regulatory Exposure
  • Strong Knowledge on #QMS (Incidents, OOT, OOS, Change controls, Investigations & CAPA)
  • Must have Strong knowledge in Software like (Empower software)
  • Must have experience in handling regulatory Audits & Customer Audits.
  • Must be good in people management.


Interested Professionals can share their Resume to "dharma.ch@hetero.com"

Should be mention subject as "SENIOR MANAGER/AGM/DGM" for Quality Control Department"

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