opening forbTrainee Auditor (clinical QA) @ Apotex Research Pvt. Ltd.
Job Description
Assists auditors, senior auditors, Team Leaders and Group Leaders in Ensuring that the assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Performing audits (both project and non-project related) to assure the compliance to GCP/ GLP, SOPs, regulatory requirements of the following departments wherever applicable; Bio analytical Operations, Clinical Operations Department, Pharmacokinetic Unit, Quality Assurance Unit, and Other general divisional operations.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Conducting in-process surveillance (both project and non-project related) to assure compliance of the Bio analytical Operations/ Clinical Operations Department/ others as applicable.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Preparation of QA audit reports for all the above audits/surveillances performed.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Conducting appropriate follow-up and take to completion any unresolved issues as a result of audit findings.
Assist to auditors & senior members in performing audit / Review of software validation packages and IQ/OQ documents for systems used within the facility.
Reports to Team Leader/Group Leader/Deputy Manager/Senior Manager R & D Quality with respect to the operational status and disposition of all matters relating to the operations in the QA unit.
Works as a member of a team to achieve all outcomes.
Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
Performs all work in accordance with all established regulatory and compliance and safety requirements.
All other duties as assigned.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:Medical Professional
Role:Clinical Researcher
Keyskills
BA BE Studies Pharmokinetics Clinical Research Clinical Monitoring Clinical QA Quality Assurance Clinical Quality Assurance QA BA Studies BE Studies
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Doctorate:Doctorate Not Required
0-1 years of auditing experience in the pharmaceutical industry.
Experience in GLP/ GCP along with strong understanding of compliance in these areas.
M Pharma - Pharmacology only
Language proficiency - Hindi is a must
Company Profile:
Apotex Research Pvt. Ltd.
Apotex Inc., founded in 1974, is the largest Canadian-owned pharmaceutical company. We employ over 6,000 people worldwide in research, development, manufacturing and distribution. We produce more than 300 generic pharmaceuticals in approximately 4000 dosages and formats and export to over 115 countries around the globe.
APOTEX RESEARCH PRIVATE LIMITED (ARPL) based at Bangalore is a 100% owned subsidiary of Apotex Inc., and is engaged in the development, bio-clinical evaluation, manufacturing and distribution of safe and efficacious generic pharmaceutical formulations for the global market.
As a part of this dynamic team, you will get to work in our state-of-the-art facilities, which include sophisticated equipments', high standard processes and the opportunity to work alongside some of the world's top professionals.
Apotex encourages the new technological developments in the field of research, manufaturing and distribution and embraces all the new techniques and technologies available in our area of concentration, our new manufaturing facility has been inaugurated in June 2012 and uses some of the most sophisticated technologies and machines available today.
Click here to apply
Job Description
Assists auditors, senior auditors, Team Leaders and Group Leaders in Ensuring that the assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Performing audits (both project and non-project related) to assure the compliance to GCP/ GLP, SOPs, regulatory requirements of the following departments wherever applicable; Bio analytical Operations, Clinical Operations Department, Pharmacokinetic Unit, Quality Assurance Unit, and Other general divisional operations.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Conducting in-process surveillance (both project and non-project related) to assure compliance of the Bio analytical Operations/ Clinical Operations Department/ others as applicable.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Preparation of QA audit reports for all the above audits/surveillances performed.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Conducting appropriate follow-up and take to completion any unresolved issues as a result of audit findings.
Assist to auditors & senior members in performing audit / Review of software validation packages and IQ/OQ documents for systems used within the facility.
Reports to Team Leader/Group Leader/Deputy Manager/Senior Manager R & D Quality with respect to the operational status and disposition of all matters relating to the operations in the QA unit.
Works as a member of a team to achieve all outcomes.
Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
Performs all work in accordance with all established regulatory and compliance and safety requirements.
All other duties as assigned.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:Medical Professional
Role:Clinical Researcher
Keyskills
BA BE Studies Pharmokinetics Clinical Research Clinical Monitoring Clinical QA Quality Assurance Clinical Quality Assurance QA BA Studies BE Studies
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Doctorate:Doctorate Not Required
0-1 years of auditing experience in the pharmaceutical industry.
Experience in GLP/ GCP along with strong understanding of compliance in these areas.
M Pharma - Pharmacology only
Language proficiency - Hindi is a must
Company Profile:
Apotex Research Pvt. Ltd.
Apotex Inc., founded in 1974, is the largest Canadian-owned pharmaceutical company. We employ over 6,000 people worldwide in research, development, manufacturing and distribution. We produce more than 300 generic pharmaceuticals in approximately 4000 dosages and formats and export to over 115 countries around the globe.
APOTEX RESEARCH PRIVATE LIMITED (ARPL) based at Bangalore is a 100% owned subsidiary of Apotex Inc., and is engaged in the development, bio-clinical evaluation, manufacturing and distribution of safe and efficacious generic pharmaceutical formulations for the global market.
As a part of this dynamic team, you will get to work in our state-of-the-art facilities, which include sophisticated equipments', high standard processes and the opportunity to work alongside some of the world's top professionals.
Apotex encourages the new technological developments in the field of research, manufaturing and distribution and embraces all the new techniques and technologies available in our area of concentration, our new manufaturing facility has been inaugurated in June 2012 and uses some of the most sophisticated technologies and machines available today.
Click here to apply
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