Pharma Bioanalytical QA Auditor Vacancy @ Syngene - Apply Online

Pharma Bioanalytical QA Auditor Vacancy @ Syngene

Syngene is hiring for Senior Executive – Bioanalytical QA Auditor. Candidates with masters degree in pharma may apply for the job opening. Pharma job opening 2022,M Pharma job opening 2022, Pharma job. Interested and eligible candidates may check out all the details on the same below:

Job Title: Senior Executive – Bioanalytical QA Auditor (48963)

Location: Bangalore

Department: Quality Assurance-GCP

Eligbility Criteria: M. Pharm

Technical/Functional Skills:

  • Should be familiar with
  • Bioanalytical methods & method validation.
  • Liquid chromatography-mass spectrometry.

Experience: 3 – 6 years

Behavioral Skills:

  • Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
  • Good speaking-listening-writing skills, attention to details, proactive self-starter
  • Ability to work successfully in a dynamic, ambiguous environment.
  • Ability to meet tight deadlines and prioritize workloads.
  • Ability to develop new ideas and creative solutions.
  • Should able to work in team and flexible for working in shifts.

Job Description:

Key Responsibilities:

  • Responsible to perform project specific bioanalytical, pharmacokinetic (PK), statistical processes and data audits as per the QA SOPs and audit programs to ensure compliance with in-house bioanalytical, pharmacokinetic / statistical SOPs and applicable regulatory guidance’s as GCP QA bioanalytical auditor as per the scheduled timelines for Clinical Development Business unit.
  • Responsible to perform audits and review of processes, raw data and documents including SOPs of bioanalytical method development, method validation, study sample analysis & reports to ensure the compliance as per the applicable regulatory guidance and in-house bioanalytical SOPs.
  • Responsible to perform audits and review of processes, raw data and documents including SOPs of pharmacokinetic/statistical data management, analysis & reports to ensure the compliance as per the applicable regulatory guidance and in-house pharmacokinetic/ statistical SOPs.
  • Responsible to perform QA review (whenever required) in the bioanalytical and pharmacokinetic/ statistical sections of the study protocols.
  • Responsible to assist or conduct periodic internal quality system or facility audits in different processes, instrumentation and software applications and its documentation in bioanalytical and pharmacokinetic/ statistical departments.
  • Responsible to assist or conduct whenever required audits of quality system or facility, as part of regulatory inspection/sponsor audit readiness program.
  • Responsible to prepare and issue audit reports and follow-up the implementation of CAPA to ensure closeout of the audits observations. whenever required assist manager/HOD to collate quality systems data for trend analysis of QA metrics.
  • Responsible to prepare QA statements for bioanalytical validation reports and final study (PK & Statistics part) reports as per the scheduled time lines.
  • Responsible to assist or conduct onsite or desktop audit of vendors as per the vendor assessment/reassessment schedule.
  • Responsible to perform QA review SOPs for bioanalytical process, instrumentation and pharmacokinetic/ statistical process to ensure the compliance with internal SOPs,
  • Applicable principles of GLP, GCLP, GCP, GDP and other applicable regulatory requirements.
  • Responsible to efficiently and professionally provide the required deliverables as bioanalytical QA auditor for GCP quality function.
  • Responsible to author SOPs for GCP quality assurance function or other relevant function’s SOPs and conduct training of relevant SOPs to staff of Clinical Development Business unit.
  • Responsible to periodically update and maintain own training records/binder and whenever required develop training plan and material and train the trainee auditors, trainee QC.
  • Responsible to be responsible for delivering discussions /presentations on topics relevant to GxPs to the research staff.
  • Responsible to collaborate with Bioanalytical /PK/Statistical functions in lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.
  • Responsible to update and consult manager/HOD when delivering the current job responsibility and escalate immediately any quality and noncompliance observations to Head of GCP Quality and Compliance.
  • Responsible to perform or assist any other relevant job with relevant training as and when required by Head- GCP Quality and Compliance or Management.
  • Responsible to periodically update the required technical, scientific, regulatory affairs knowledge with respect to the required national & international drug regulatory guidance and quality standards.
  • Follow environment, health, and safety (EHSS) requirements at all times in the workplace ensuring individual and lab/plant safety.
    Attend training on environment, health, and safety (EHSS) measures imparted company.

Click Here To Apply Online

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