Job Title:  Assistant General Manager- Late Phase QA

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

Department: Late Phase QA

Designation: Assistant General Manager

Job Location: Ahmedabad (Gujarat)

Education: M.Pharm/Ph.D.

Experience: 15+ years

CTC Range: 20 to 30 Lacs

Job Description:

• Ensure data compilation for Quality Review Board Meeting for Late Phase trials and functions; Data compilation, meeting preparation and discussion, MOM preparation and further followup of action items.
• Review effectiveness of CAPA management (identification, reporting, impact assessment and CAPA implementation) and Review of various study documents.
• QA statement and Audit certificate issuance as per applicable regulatory guideline.
• To determine whether all trial related activities were conducted, data recorded, analyzed and reported accurately & in compliance to all applicable Regulatory requirements, Organizational requirements (Policy, Procedures and processes) and Client’s requirements (protocol, contract etc.) by routinely conducting audits (In process, on-site and off-site) at various stages for allassigned projects.
• Conducting & reporting of system audits as per system audit annual calendar to ensure compliance w.r.to current ICH GCP, Lambda SOPs, Quality Systems, Protocol and applicable regulatory requirements.
• Participate in key internal project team meetings and facilitate quality discussions during these meetings, as appropriate.To Support Head- QA/Designee for preparation & review of QA sops and review of system sops of other department (Clinical Trial Management, Medical affairs, medical imaging) for
  correctness, adequacy and compliance.
• To provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections.
• To support Head-QA/Designee for handling regulatory inspections and sponsor system audit, arranging data for regulatory inspection and sponsor system audit, responding to regulatory or sponsor queries pertaining to clinical trial/medical imaging issues, co-ordinate for regulatory/sponsor inspections/audits.
• To perform retrospective audits of Study protocol and study related raw data, as required.
• Update Head-QA/Designee regularly on the level of compliance and compliance issues.

COMPETENCIES