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JD for Validation Deputy Lead
Overall responsible for review and approval of protocols, ensuring process validations, cleaning validations, hold time studies, transport validations and product related validations are planned, executed as per laid down procedures and schedules, review and approval of reports, implementation of recommendations.
Strategic planning and scheduling of activities within team members of Quality Assurance and coordination with cross functional teams to ensure smooth, cGMP and quality compliant manufacturing process.
Responsible for timely closure of summary reports
Responsible for Review of Validation Master plan.
Responsible for continuous process validation
Responsible to lead internal and external audits. The coordination involves liaising with all Head of the Departments during the audits for furnishing the requirements as requested by the auditor(s), to be with the auditor during the audit rounds and meeting, document review as deemed necessary and intimated by reporting authority. Responsible to provide appropriate technical responses during the audit. This also includes convening internal meetings periodically before the audit to review the preparedness as well as meetings during the audit days to understand the possible issues raised during the audit in order to identify and implement appropriate action plan to be presented to the auditor. Identifying, monitoring compliance to CAPA identified as an outcome of audit observations.
Responsible to nurture a well-trained and motivated team as well as establish and maintain a positive community relationship with the peers, superiors and subordinates.
Responsible for allocating key performance areas / quality goals for the team members in validation department for continuous quality improvement.
Involve in continuous improvement plans by effective quality gap analysis programs, from the learnings obtained as part of internal and external audits as well as with changes in the regulatory expectations.
To actively participate QMS meetings with peers and superiors. Update and discuss issues, if any with the higher management in order to find an effective solution keeping product quality, safety and efficacy as the top priority.
To approve the documents and records prepared for the applicable section as and when required.
Trouble shooting and root cause analysis with providing effective corrective actions and preventive actions for all non-conformances / out of specifications / out of trends / complaints / product recalls, etc.
Coordinate with India team for harmonized Quality Assurance Procedures
Ensure that Validation activities are carried out using approved materials and procedures, trained / qualified / certified people, calibrated instruments, facility etc.
Ensure that CPP and CQAs are trended and if any out of trend is investigated as per the approved procedures.
Field of Study
Kindly contact Mr Hanafi at 019-7851503 / 07-230 5453 ext 21 email [ email@example.com ] for further details