Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.
Post : Auditor - Quality R&D
Job Responsibilities
• Ensures that assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable.
• Performs 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.
• Conducts in process surveillance (both project and non-project related) to assure ongoing compliance of the Bio analytical Operations/Clinical Operations/others Department as applicable.
• Prepares QA audit reports for all the above audits/surveillances performed.
• Conducts appropriate follow-up and take to completion any unresolved issues as a result of audit findings.
• Performs audit / review of software validation packages and IQ/OQ documents for systems used within the facility.
• Assists in the formal training of new and existing QA staff members to both QA and facility audit and procedures.
• Revise, implements, and maintains records of standards Operating procedures and additional relevant documents for the facility.
• Assists in System Audits whenever required.
• Reports to Team Leader/Group Leader/Deputy Manager/Manager 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 ValuesDemonstrates 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.
Candidate Profile
• M. Sc., /M. Pharm., /B. Pharm.
• 2-3 years of auditing experience in the pharmaceutical industry.
• Experience in GLP/ GCP along with strong understanding of compliance in these areas.
Additional Information
Qualification : M.Pharm, M.Sc, B.Pharm
Experience : 2-3 years
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality R&D
End Date : 25th November, 2018
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