1.Conducts scheduled audits in accordance with QA (Quality Assurance) risk-based processes.
2. Assesses compliance of clinical investigator sites, vendors, study activities, pre-clinical research activities, data, and reports, submissions, and occasionally PCO (Pfizer Country Organization) processes against ICH (International Conference of Harmonization), applicable government agency regulations/ guidelines, as well as Pfizer policies, procedures and industry standards. Demonstrated solid working knowledge of Quality Assurance and wide range experience in auditing.
3.Conducts QA (Quality Assurance) audits, reports results to project team personnel and management, and interacts with various teams to ensure corrective actions are taken to bring QA observations to closure as applicable.
(i)Audit preparation and notification to key stakeholders (e.g. review of audit and inspection history and SOPs)
(ii)Conducts audits of clinical investigator sites, nonclinical laboratory studies and vendors of same.
(iii)Conducts audits of regulatory documents and marketing applications.
(iv)Occasionally conducts PV (Pharmacovigilance) related audits at Pfizer sites/country organizations, and vendors.
4.Partners with Bus (Bussiness Units)/RUs (Regional Units)/Partner Lines, providing guidance and QA expertise on relevant GCP (Good Clinical Practices), GLP (Good Laboratory Practices), PV issues. Regularly participating in project and cross team discussions and uses straight talk.
5.Delivers awareness sessions with oversight by manager on various GCP (Good Clinical Practices), GLP(Good Laboratory Practices), PV (Pharmacovigilance) topics internally and externally.
6.Assesses area of greatest risk and develops strategic plan based on knowledge of relevant SOPs (Standard Operating Procedures), GCP (Good Clinical Practice), GLP(Good Laboratory Practices), PV (Pharmacovigilance) regulations and guidelines as well as local regulations.
7.Establishes proficiency in the use of different Pfizer systems.
8.Interacts with QA colleagues at other Pfizer locations to ensure consistency in application of the QA strategy and to promote standardization of auditing approach within QA.
9.Generally suggest new audit techniques/aids; may suggest controls to consider.
10.Actively participate in special assignments on various project teams and work streams as determined by QA management.
11.Creates solid customer relationships and regularly provides advice regarding quality improvements for stakeholders.
12.Assists with regulatory inspections or corporate audit activities.
13.Ensures rapid communication of QA issues, including potential misconduct or issues of significant deviation with projects/products, to appropriate leaders and colleagues.
14.Provides training to less experience members of MQA (Medical Quality Assurance) staff.
15.Participate in appropriate activities to influence and meet the changing needs of the regulatory environment through QA and other appropriate venues.
16.Demonstrates ability to work in a culturally diverse environment.
17.Demonstrate OWN-IT behavior.
18.Requires approximately 40-60% time for conducting audits (including travel) and attending QA meetings. For site based auditors (i.e. GLP), the travel requirement is up to approximately 25%.
Manpower Management and Training :-
1.Promote a healthy and teamwork oriented atmosphere within unit
2.Prepare a manpower budget as per the growth in the operations of the unit
3.Identify the training needs of his team and assist in the development of modules to address the same
4.Ensure that unit are at their optimum staff strength
Systems Implementation and Process Management :-
1.Ensure that all the systems and processes are implemented and followed as per the company policy
2.Responsible for following up on the effectiveness of each process and provide details on alterations to be made to the same
Salary: Not Disclosed by Recruiter
Functional Area:Analytics & Business Intelligence
Role Category:Analytics & BI
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
PG:M.Tech, MS/M.Sc(Science), M.Pharma
Doctorate:Doctorate Not Required
Zeon Lifesciences Limited
Recruiter Name:Amit Ranjan
Contact Company:Zeon Lifesciences Limited