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Working as Quality Manager at Clinical Development Services Agency (CDSA)
- May 1, 2018
- Posted By : admin
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Name of the Position :Quality Manager (Preterm Birth Program)
Emoluments :Up to Rs. 55,000 per month up to December 2018 likely to be continued
Location : Gurgaon Civil Hospital, Gurgaon
Job Profiles:
Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
- Actively lead or assist activities in the areas of Internal Quality improvements and CAPA (Corrective and Preventive Actions).
- Ensure that assigned study is conducted in accordance with study protocols, GCP guidelines, and applicable regulatory requirements.
- Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk
- -based methodology.
- Proactively identify the project risks and assist in providing training to study staff in good clinical and documentation practices.
- Maintain GCP compliant processes which control the quality of work at the study site
- Conduct source document verification and case record forms for assessing the study trends
- Overseeing and/or performing quality functions and executing quality programs (clinical operations, clinical laboratory, data management review)
- Collaborate with clinical and project management team to ensure compliance with quality standards, timelines and appropriate follow-up in areas of deficiency
- Coordinate expert monitoring visit/ audits as per project requirement.
- Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
Qualifications and Experience
Master’s degree in life sciences or biomedical sciences or pharmacy or Public Health or Clinical Research.-
4- 5 years of demonstrated experience in the area of Quality Control, Quality Assurance and Clinical operations. GCP/ GLP trained and experience of handling observational studies will be preferred.
Age limit : Not exceeding 40 years
Skills:
- Ability to gain trust and confidence with stakeholders.
- Operational skills including focus and commitment to quality management and problem solving
- Influencing skills including negotiation and teamwork
- Effective communication skills, the provision of timely and accurate information to stakeholders
- Understanding of GCP, regulations and guidelines
- Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
- Fair and ethical. Creates a culture that fosters high standard of ethics.
- Basic business computer skills (MS Word, Excel, e-mail)
How to Apply:
- All educational professional and technical qualification should be from a recognized Board/ University and full-time.
- The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
- Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
- The qualification, experience and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified.
- Interested candidates may please send their current CV ( Resume) along with the application form (attached on CDSA website) with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references along with the attached datasheet and excel sheet posted in the website. E-mail should be submitted with subject line Application for the post of “Quality Manager (Preterm Birth Program)” to [email protected]. The last date of receipt of application is May 13, 2018.
- Email application without clear subject line and incomplete applications will be summarily rejected.
- Only shortlisted candidates will be contacted for further discussion
- The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is an actual and will be based on experience, qualifications, skill set, etc. of the candidates.
- This position is strictly project-based.
- All results will be published on our website and all future communications will be only through email.
Last date of receipt of applications will be up to 13th May 2018. Those who have applied earlier need not apply again.
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