Assistant Manager -QA (clinical Research-ba/be & Clinical Trials)
by Jubilant Clinsys Ltd in Noida
Experience: 4 to 6 yrs. | Opening(s): 1 Posted on: 10 Sep
Job Description
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Assistant Manager
DEPARTMENT: Quality Assurance
MINIMUM REQUIRED EDUCATIONAL QUALIFICATION
B.Pharm/M.Pharm/M.Sc
MINIMUM REQUIRED EXPERIENCE
4 to 5 Years
Key Responsibilities
Responsible for understanding regulatory guidelines, Standard Operating Procedures
Review Standard Operating Procedures for all departments during initial development, preparation and revisions
Provide technical and regulatory expertise in the development and application of procedures, training materials, communications, and/or tools
Coordinate the delivery of education and training initiatives to the staff involved in studies
Liaison between Clinsys staff and external agencies during regulatory inspections or Sponsors Due Diligence Visits and Study Audits
Provide training, coaching and mentoring of staff in the Quality Assurance (QA) Department
Liaison between Clinsys staff and Sponsors/Clients/Regulatory Authorities during audits and inspections
Develop audit plans and conduct audits of BA/BE and Phase I IV studies, including Protocols/Amendments, Trial Master Files/Central Files, Databases (clinical and drug safety), Tables, Listings and Graphs, SAEs/narratives, Clinical Study Reports, Regulatory Submissions, Third Part Organizations, Vendors, Investigator Sites, facility, systems and processes to ensure compliance with regulatory guidelines and Standard Operating Procedures
Serve as Lead QA for identified function
As a lead QA, ensure that SOPs are current as per the regulatory requirements. Responsible for identifying gaps in the identified function and proposing requirements to the management
Prepare and review comprehensive audit reports and communicate audit findings from audits to management ,department heads and auditees as appropriate
Follow up all audit reports for completion of corrective and preventative actions (CAPA) and timely closure of the audit reports
Provide department heads with reports, assessing root causes and compliance feedback, and including follow-up actions
Conduct trend analysis of issues identified during internal audits across the organization and share with the teams
Conduct audits of vendors when key processes are outsourced to third parties
Manage the archival and retrieval of documents provided by different departments as applicable
Responsible for preparation of business process maps for different activities conducted at Clinsys Clinical Research.
Distribute new/revised Standard Operating Procedures to respective departments/locations and withdraw retired Standard Operating Procedure when applicable
Manage the issuing of forms to different departments per Standard Operating Procedures when applicable
Assistant Manager
DEPARTMENT: Quality Assurance
MINIMUM REQUIRED EDUCATIONAL QUALIFICATION
B.Pharm/M.Pharm/M.Sc
MINIMUM REQUIRED EXPERIENCE
4 to 5 Years
Key Responsibilities
Responsible for understanding regulatory guidelines, Standard Operating Procedures
Review Standard Operating Procedures for all departments during initial development, preparation and revisions
Provide technical and regulatory expertise in the development and application of procedures, training materials, communications, and/or tools
Coordinate the delivery of education and training initiatives to the staff involved in studies
Liaison between Clinsys staff and external agencies during regulatory inspections or Sponsors Due Diligence Visits and Study Audits
Provide training, coaching and mentoring of staff in the Quality Assurance (QA) Department
Liaison between Clinsys staff and Sponsors/Clients/Regulatory Authorities during audits and inspections
Develop audit plans and conduct audits of BA/BE and Phase I IV studies, including Protocols/Amendments, Trial Master Files/Central Files, Databases (clinical and drug safety), Tables, Listings and Graphs, SAEs/narratives, Clinical Study Reports, Regulatory Submissions, Third Part Organizations, Vendors, Investigator Sites, facility, systems and processes to ensure compliance with regulatory guidelines and Standard Operating Procedures
Serve as Lead QA for identified function
As a lead QA, ensure that SOPs are current as per the regulatory requirements. Responsible for identifying gaps in the identified function and proposing requirements to the management
Prepare and review comprehensive audit reports and communicate audit findings from audits to management ,department heads and auditees as appropriate
Follow up all audit reports for completion of corrective and preventative actions (CAPA) and timely closure of the audit reports
Provide department heads with reports, assessing root causes and compliance feedback, and including follow-up actions
Conduct trend analysis of issues identified during internal audits across the organization and share with the teams
Conduct audits of vendors when key processes are outsourced to third parties
Manage the archival and retrieval of documents provided by different departments as applicable
Responsible for preparation of business process maps for different activities conducted at Clinsys Clinical Research.
Distribute new/revised Standard Operating Procedures to respective departments/locations and withdraw retired Standard Operating Procedure when applicable
Manage the issuing of forms to different departments per Standard Operating Procedures when applicable
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Medical Professional
Role: Clinical Researcher
Keyskills: Quality AssuranceBA / BEClinical ResearchClinical Trials21 CFR part 11
Desired Candidate Profile
Education:
Please refer to the Job description above UG - Any Graduate - Any Specialization
PG - M.Pharma - Pharmacy, M.Sc - Any Specialization
Doctorate - Doctorate Not Required
PG - M.Pharma - Pharmacy, M.Sc - Any Specialization
Doctorate - Doctorate Not Required
Company Profile
visit at: www.clinsys.com
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