Manager

Role & responsibilities

Activities to be performed with the compliance of ISMS requirements by means of confidentiality, integrity, and availability.

Data integrity must be followed and ensured in all the respective responsibilities.

Audits:

• Sponsor Audits:
• Managing the sponsor audits as a whole, from pre requestees to close out meeting.
• Addressing audit observations within timeline.
• Follow up sponsors for certificates/clearance.
• Standard Audits:
• Ensuring the readiness for Audit.
• Supporting the cross functions for readiness requirements.
• Managing the audit from open meeting to close out meeting.
• Addressing the observations.
• Vendor Audits:
• Initiating the vendor qualification process based on requirements.
• Conducting onsite vendor audits with respect to ISO 9001:2015, ISO27001:2022 or other applicable ISO standards.
• Assessing the potency of vendors for iVRS service.
• Issuing audit observations, verification of CAPA and issuance of certificates.
• Verifying the surveillance audit due dates and initiating the surveillance audits within timeline.
• Score card updates for vendors.
• Internal Audit:
• Conducting Internal audit as per iVRS internal audit SOP,
• Ensuring the compliance with respect to internal SOPs, regulatory guidelines, etc
• Issuing the audit reports, verification of CAPA, closing the Audits.
• MRM:
• Facilitating the MRM upon completion of Internal audit under MR supervision
• Requesting cross functional inputs
• Making the MRM presentation

Analytical Development:

• Develop documentation and system as per Quality Management System and ensure its implementation in the laboratory.
• Preparation of manuals and policies.
• To review the Manuals, Standard Operating Procedures, and other quality documents and approval of the same.
• Review and Approval of study protocols, Validation protocols, Qualification protocols and CSV protocols
• Review and approval of Validation reports, Qualification reports and CSV execution and reports.
• Develop, implement, and manage processes to ensure that studies / project activities meet required specifications for quality, function, and reliability prior to submission of data to the sponsor/customer.
• Review and approve of project / study documents related to analytical department to ensure its compliance with inhouse SOPs, study specific protocols, and applicable regulatory requirements & guidelines.
• Monitoring and ensure that the lab is following practices/ procedures laid down by way of regular planned and unplanned audits.
• Customer query- to register the query received from customer and handling the investigations
• Review, monitoring and data compilation of customer queries.
• Implementing, maintaining and improving the established analytical lab and in-process processes and methods.
• Verifying and approving the Laboratory incidents and investigations
• To oversee the activities with respect to Quality Management Systems and Learning and Development.
• Verification and approval of calibration documents.
• Verification of Audit trials in various instruments for validation, study and calibrations.
• Verification of biannual audit trails
• Attending all mandatory trainings (as applicable) without fail.

Clinical Development:

• Conduct inspections or test checks to determine if all studies are conducted in accordance with the Principles of Good Clinical Practice
• Review of protocol and other study related documents
• Site visits whenever required.

QMS:

• Verification of Procedures for its adequacy, To review and approve master list of SOPs. (as a backup to the designated employee)
• Preparation of new procedures and revision of existing procedures.
• Preparation, review, approval of Quality assurance procedures.
• Review and approval of cross function procedures.
• Verification, authorization/approval/Closure of Change controls, LIR and other QMS forms.
• Verification and approval of QMS trending.
• Review IQ, OQ, PQ records, Calibration certificates and Computer System Validation for Automated Software, as per 21 CFR Part 11 compliance.
• Ensure to follow and accomplish the Quality Objectives and ISMS objectives.
• Preparation / Verification of QA and ISMS objectives and actuals, Actuals, Risk assessments, Asset lists, etc

Training:

• Ensuring the annual training schedule.
• Ensuring the mandatory trainings are conducted as per schedule.
• Ensuring the identified trainings are conducted for team members.
• Planning regulatory and QA trainings.
• Conducting BCP-DRT meetings.
• Ensuring the surveillance audits and ensuring the internal feedbacks.