Associate Director - Quality Assurance - Pharma

We have an urgent requirement for a leading pharmaceutical company for the profile of "Associate Director-Quality Assurance"

JD

Internal Audits:

- Prepare & Approve Global Audit Plan for all Indian and Overseas sites considering the risk based approach and take decisions on frequency of internal audits in these units;

- Review Audit reports conducted by the team and assess the risks associated; Share the observations with the respective unit teams for CAPA & escalate the risks with the Quality Head and the Senior leadership team across the units in order to ensure anytime audit readiness and to highlight risks which may lead to critical observations during external audits

Customer & Regulatory Audits :

- Liaise with auditors throught the audit process for all Regulatory audits and key customer audits; facilitate discussions between auditors and employees; provide clarifications where required;

- Guiding the team in performing pre-audits prior to major customer audit/ any regulatory audit; Support the unit teams/QA teams in regulatory or customer audits with facilities & documentation;

- Facilitate in conduction- to -closure of the regulatory audits; Drive audit response process along with local teams once the audits are over and ensure that the responses are sent back on-time in order to ensure smooth handling of external audits.

Vendor Audit Support :

- Extend support to vendor audits in conducting vendor - Third party & strategic business partners (facilities & documentation) qualification audits & prepare and sign-off audit report ;

- Conduct audits & help prepare the vendors' sites for regulatory audits of those vendors in order to ensure cGMP compliance.

Pre-Submission Reviews :

- Set the process and Guide the team in conducting product specific audits at CTO/FTO sites wrt regulatory filings (DMFs/ANDAs/Dossier) as and when need arises;

- Review the audit reports and sign-off on CAPA identified in order to ensure compliance wrt the facility & documents and also to ensure audit readiness in future course.

Follow-ups for closures & knowledge sharing :

- Monitor & follow up for closure of CAPA with site QA teams by extending support to these teams in working on the issues identified in the audit responses;

- Conduct Audit analysis in terms of open v/s closed observations on a monthly basis and upload the same on eQMS database in order to ensure compliance related improvements across the units and make them ready to face the audits.

Training & Knowledge sharing :

- Conduct training need analysis based on the observations on the audits ; Prepare & share audit summaries (day wise) with the prospective units to be audited;

- Share learning (best practices, major NCs ) from the audits across the units/businesses in order to build unit/.business level capability in terms of compliance & audit preparedness.

Quality Review Board & QMS Initiatives :

- Provide inputs to Quality Head and make presentations for the Quality review board on quarterly basis, highlighting potential risks and major issues from audits etc. in order to strengthen existing QMS.

People Management & Organization Building :

- Conduct goal setting, performance appraisals, coach employees, participate in recruitment and induction, identify training needs, based on future plans and business requirements, provide training on specific capabilities to team, identify and recommend retention plans in order to empower people so that they could contribute to the achievement of business targets.

Candidate with regular M.Sc Can only apply with 60%

Shilpee Karan