DGM Investigation & Compliance

Position Summary :

- Overall responsibility with respect to all aspects of Handling Product Quality Complaints (PQC- s) globally in Quality department and will be responsible for receiving, assessment, evaluation, holistic investigation, finding out root causes, taking adequate corrective actions and implementing robust preventive measures to minimize or avoid future complaints from market.

- The position will also be responsible for activities resulting from actions derived from Global Safety Board (GSB), Human Safety Group (HSG), Safety Operations Group (SOG), and Quality Management Group (QMG).

Job Responsibilities :

PQC process handling :

- Logging of all PQC's received from various markets

- To maintain a master database of each complaint case for product complaint details, product details, patient / consumer details etc., and to assign a unique number for tracking the case till completion.

- Oversee and monitor the progress of investigation consistently and continuously to complete the investigation within designated timelines

- Ensure all the PQC's are adequately and appropriately investigated by identifying the root cause and taking robust and rugged corrective and preventive actions thereby restricting the recurrence of complaints per site.

- Ensure that the findings or investigational details are logically documented and rationale listed regarding the outcome of the investigation. The investigation reports shall be well written to put Glenmark in a defensible position regarding each potential case.

Post Marketing Surveillance :

- Ensure implementation of Global Safety Board guidelines as per applicability.

- Ensure all the actions resulting from decision that HSG, QMG and SOG taken are well understood, implemented and trained to each individual responsible for such actions.

- Ensure that the PQC management process is completely aligned with the Medical and Pharmacovigilance processes globally.

- Shall be capable to evaluate each and every case as to its criticality of safety and health impact to patient and decide the necessity of a Field Alert reporting to Health Authorities.

- Shall ensure all such decisions are documented with adequate reasons even though a decision of not to file an FAR is taken.

Performance Metrics / Statistical trends :

- Ensuring that the master data base is up to date with each case details, investigation outcome and CAPA taken.

- From the master database, there shall be data evaluated and trends derived based on the nature and kind of complaints received.

- The trends are statistically evaluated and projected with innovative information which may be useful for a fresh investigation or an extended investigation.

- Shall have the ability to correlate the data from master data base and shall be able to infer meaningful patterns derived out of such exercises.

- All potential / significant complaints received from DQRS and / or DMRC or any Health Authority shall be dealt in a quick manner with complete preliminary information needed to replenish the kind of questions coming from such agencies.

- Effectiveness of investigation shall predominantly show a progressive behaviour as the data from statistics reveal innovative and undiscovered information for either an extended investigation or a breakthrough for a current investigation.

- Ensure all such gathered innovative information and regular complaints trends are presented monthly in Operations and Quality MIS and use these presentations to train the site personnel to prevent such complaints.

- Ensure risk assessments of all the processes and sub processes carried out in the site, in order to identify gaps and work towards - zero- market complaints and batch failures.

- Coordinate with departments, such as procurement, purchase dealing with external vendors to develop, identify corrective and preventive actions at the vendors end and its relevant compliance.

- Keep a close track of CAPA logged at sites and extend global CAPA's to other sites and implement similar actions as per applicability.

- Perform effectiveness of CAPA's implemented for significant and potential cases so as to prove that the actions taken are giving intended positive results.

Compliance :

- Ensure that the site activities are complaint to all regulatory and safety requirements at all times in terms of PQC's and ensure all the CAPA identified are well implemented and effectiveness checked.

People :

- Ensure that an enabling environment is in place so that all employees in the span of responsibility are motivated at all times, through regular communication, cross functional movements, training, proper goal setting, reviews/feedback on performance and rewards & recognition

- Ensure best in class talent is hired and retained across the team.

- Lead for the preparation of regulatory and customer audits

- Control attrition within target. People development through training and talent management activities.

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