Job Description

JOB DESCRIPTION:

• To ensure compliance from training standpoint during audits.

• To impart/coordinate for completion of various types of trainings like on job trainings, refresher trainings, ILT trainings.

• To ensure training completion of QA/ QC.

• To ensure SOP training of staffs are performed prior to execution of critical tasks.

• To ensure the effectiveness of training provided to employees and assessment of effectiveness of overall training program through periodic, for-cause or routine audits.

• To establish training documentation standards to ensure appropriate retention, archival and retrieval processes for executed training records and training materials.

• To review and approve the Department Training Plan Matrix which defines the training curriculum required for each job role. To review, manage, document and approve any changes to curricula through Department Management.

• To provide support for GQS/GSOP implementation at site by assessment and evaluation of these Global documents as per established standard procedure(s).

• To maintain all time SOP readiness by updating SOP master list.

• Ensure that internal audits are executed as per pre-approved schedule and strategy in accordance with established SOPs and cGMP regulations.

• Ensure that documents required for internal audits are timely approved and shared with concerned auditee(s)/departments

• To coordinate for finalizing of audit team based on objective and scope of audit, to coordinate with corporate quality assurance during site audits as required

• To perform QA review and classification of observations during internal audits

• Ensure that audit observations are adequately documented into audit report and shared with concerned stakeholders within stipulated timelines as mentioned into SOPs

• Ensure that audit responses are received and reviewed for completion and justification as required; also CAPA (s) are provided with timelines

• Ensure that CAPA (s) are implemented as per compliance procedure, effectiveness is monitored and documented as per SOP requirements

• Ensure that trending of audit observations are compiled, reviewed and approved as per timelines mentioned in SOP

• Ensure through continuous monitoring at shop floor that all time readiness (ATR) is maintained at Site

• Ensure that implemented CAPA (s) and previous audit observations are in-compliance to response provided

• Identify continuous improvement opportunities to increase compliance, process clarity, and operational efficiency.

• Provide appropriate trainings and development to support staff to meet their respective job responsibilities.

• To conduct impact assessment and risk classification for audit observations, deviations/change controls/investigations and other CQMS records.

• To ensure that engineering calibration certificates, layouts and other documents related to utilities and facilities are approved in a timely manner.

• To provide QA support for approval and closure of investigations, deviations, out of specifications, CAPA and out of trend results.

• Ensure coordination with cross-functional team for timely and effective implementation of quality system related projects and trainings.

• The assessment of the laboratory deviations, lab events, investigations for non-conformances in laboratory with Good Laboratory Practices, Standard Test Procedures and Specifications.

• The assessment of the laboratory investigations/shop floor investigations of Out of specification and verification of the data.

• Final review of analytical data and manufacturing documents of exhibit batches for clearance to regulatory filing.

• To ensure compliance to cGMP, review and track non-conformances and QC data as required by laboratory QA procedures. Immediately communicate significant concerns identified to QC Head, QA Head and Site Quality Head to ensure that questionable test results are not released. Ensuring the implementation of CAPA.

• Assist with and /or advise on laboratory procedure development and implementation as requested or necessary to support continuous improvement. Perform periodic review of SOPs as per schedule.

• To participate in Management Review Meetings and other Quality Team Meetings.

• Review and approve exhibit stability protocols generated by PDR/PDL/Stability department.

• To ensure implementations and compliance of CAPA on observation of regulatory audits and internal audits conducted by QA and CQA with respect to laboratory compliance.

• To review and approve qualification and validation protocols /reports/-laboratory equipment qualification, analytical method validations/verifications.

• To investigate the cause of observation of audits (internal, external and regulatory) on laboratory control systems and to implement CAPA.

• To do risk assessment of current state of compliance with proposed effective pharmacopoeias changes/variations under approvals.

• To ensure Quality and compliance of standalone computerized systems.

• To ensure quality and compliance of computerized systems for any upcoming activity.

• Participation in self-inspection activities as subject matter expert.

• Review and approval of change controls.