Synergen Bio Private Limited is a new age CRO with all necessary infrastructure to cater to the Pharmaceutical and Biotech industry, established by a enthusiastic professionals with a vision to set-up a premium Clinical Research Organization known for its Quality, Knowledge and Expertise.Our mission is committed to offer total service satisfaction to our customers and strives to achieve the goal of excellence, through a continuous improvement of our processes, systems and services, in delivering high quality projects meeting regulatory requirements in full compliance with GCP, GLP and ensuring adherence to approved protocols, regulatory, ethical and scientific norms.
Synergen BIO Private Limited Recruitment Details:
- Position: Clinical QC Manager
- Qualification: MSC / B. Pharm / M. Pharm
- Experience: 6 to 10+ years
- No Vacancy: 1 (Immediate joiner preferred)
- Job Location: Shivajinagar, Wakadewadi, Pune
- Preparation and review of Clinical Standard Operating Procedures (SOPs) for adequacy, correctness, and completeness.
- Preparation of checklists for Quality Control Audits.
- Conducting SOP training and suggesting modifications in current processes to improve quality and minimize errors.
- Planning and conducting in-process audits of various Clinical phases, including Registration, Screening, ICD Distribution, ICD Presentation & Obtaining, Medical Examination, Breath/Urine Alcohol Test, Urine screen for Drug of Abuse, check-in, Pre-dose vital examination, Dosing, Blood Sample Collection, Protocol Restrictions, Meal, Sample Processing & Storage, Vital Examination, and Check-out, Ambulatory sample collection, etc.
- Retrospective review of Clinical Study Documents like Screening Records, Study Case Report Forms (CRF), Informed Consent Documents, Medical Reports, and Source Documents.
- Planning and conducting audits of various sections of the Clinical Research Department (e.g., Screening, ICU, Housing, Sample Processing & Storage) to ensure regulatory, SOP, and protocol compliance.
- Preparing audit reports and forwarding the audit observations to the Clinical department Head/Principal Investigator (PI).
- Tracking instrument calibration schedules and preventive maintenance schedules and maintaining records.
- Preparation of Sponsor Audits and Regulatory Inspections.
How to Apply:
Interested candidates should share their CV via email at firstname.lastname@example.org
Please note that the qualifications and experience required for this role are significant, and it involves overseeing various aspects of quality control and auditing within the clinical research field. If you meet the qualifications and have relevant experience, you should consider applying for this position by sending your CV to the provided email address.