Manager

Role & responsibilities

Activities to be performed with the compliance of ISMS requirements by means

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.