Biosite hiring M.Pharmacy, MBBS, MD Pharmacology Candidates for Medical monitor, Clinical Quality Assurance Departments in Bangalore location

Details of Job Description, eligibility, Educational Qualification and More information check below.

Post: Medical Monitor (Full Time)

Location: Bangalore/ Work From Home

Qualifications – Medical Degree; MD (Pharmacology)

Medical operational excellence, time and risk management skills;

Excellent technical (scientific) editing and writing skills;

Excellent English language knowledge

Requirements of the job

Experience – > 5 years’ experience medical affairs, clinical development, pharmacovigilance.

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Post: Manager – Clinical Quality Assurance (GCP)

Location: Bangalore/ Work From Home

Qualification – M. Pharmacy / Pharm D ( Preferably Pharmacology / Clinical Pharmacy)

Experience: 1-5 Years

Job description

Prepare and conduct routine internal audits of projects conducted at the site as schedule Job description , Prepare and conduct routine internal audits of projects conducted at the site as scheduled.

These audits are intended to assess Biosite Research sites compliance with Good Regulated Practices (GCP), Quality System Documents (such as SOPs), study protocols, pertinent industry regulations and guidelines; they include, but are not limited to, the following:

  1. Study authorization to proceed – screening & randomization
  2. Pre-study (documentation) audits

iii. In-process (procedures and documentation) audits

  1. Post-study (documentation) audits
  2. Statistics and/or pharmacokinetics
  3. Clinical study reports

vii. CDISC audits

viii. Trial Master File audits

  1. Validation reports
  2. Review protocols, informed consent forms, source document templates/logs and

other project-specific documentation not otherwise reviewed formally in an audit.

  1. Prepare and conduct external audits for clinical trial projects and pharmacovigilance

projects to ensure compliance with SOP, Protocol, ICH GCP, quality system and

applicable regulatory requirements

  1. Prepare and conduct routine process/system audits, as well as audits of validation

and/or qualification of computerized systems and facilities.

  1. Prepare and conduct qualification surveys and/or audits of 3rd party vendors that

provide goods and/or services that support GCP activities at Biosite Research.

  1. Keep QA Management up to date with findings and follow up on corrective actions.
  2. Analyze and evaluate available data and timely prepare written Audit Reports of findings and observations to be shared with site and senior management.
  3. Perform adequate and timely follow-up of audits, and issue Quality Assurance statements /certificates for audits conducted.
  4. Create Quality Plans, Audit Plans or Audit Checklists for assigned projects.
  5. Coordinate with site QA management in the submission and effective maintenance of quality – related data for the development and tracking of quality metrics.

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