Require Research Scientist at Apotex@ Click Here for more details

Post : Research Scientist I- Bioanalytical

Job Summary
Under supervision of Team Leader or Group Leader or Dy.Manager, responsible for developing, validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applies assay for the analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques.  Responsible for interpreting data and completing the required reports and documentation.

Job Responsibilities
• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre’s, Standard Operating Procedures and in a consistent manner consistent with current regulatory ( DCGI- CDSCO,TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations.
• Performs bioanalytical method development and validation for the quantification of drugs and metabolites.
• Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems.
• Sets-up and ensures calibration of analytical systems and maintains instrument systems in good working order.
• Documents all the work and results of all assignments as required.
• Assists in the preparation of lab reports.
• Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management.
• To receive the plasma samples from the clinic and ensure their proper storage until further assay
• To write and revise SOPs as per need and maintain awareness of and adherence to all current SOPs.
• To oversee the raw data compilation and their archiving after completion of final reports.
• Performs routine maintenance on Mass Spectrometers and associated HPLC equipment.
• Applies assay for the routine batch analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques.
• Performs additional related duties as assigned by Management.

Candidate Profile
• Minimum M.Sc. / M. Pharm / Ph.D
• 4 to 6 years of experience in Bioanalytical Laboratory.
• Knowledge of computerized data acquisition systems.
• Good knowledge of GLP requirements

Additional Information
Qualification : Ph.D, M.Pharm, M.Sc
Experience : 4 to 6 years
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Bioanalytical
End Date : 30th April, 2019

Require Associate, Senior Associate at Apotex @ Click Here for more details

Post : Associate/Sr Associate, GBS - Global QC Stability Data Analytics

Job Description:
Job Summary 
Responsible to summarize and review stability data to ensuring that Apotex commercial products’ shelf lives are supported. Responsible to perform Stability data trending for investigations and for Annual Stability Summary Review packages for the APQRs to ensure compliance with established timelines and Good Manufacturing Practices. Provide required stability data to customers for their product compliance files.

Job Responsibilities
• Prepare, review and publish Stability Summary Reports within compliance time frame.
• Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers.
• Review Stability data from third party affiliates for compliance.
• Perform Stability Impact Assessment for out-of-trend results obtained at release for drug product as per approved procedures.
• Perform shelf life extensions or reductions for product as required and as per approved procedures.
• Perform trend analysis as requested by the customers and as per approved procedures.
• Review and evaluate Stability data for the product to ensure that no significant trends are developing that warrants attention and that the approved shelf life continues to be justified.
• Interpret statistical analysis from NWA.
• Provide Annual Stability Review contribution packages to QA Product Review group for the Annual Product Quality Review (APQR). Notify Team Leader of any adverse trends detected.
• Works as an effective team member to meet department goals, sharing knowledge with team members.
• Maintain compliance to all health and safety standards, Good Manufacturing Practices, Good Documentation Practices and regulatory requirements. Responsible and accountable for compliance with all aspects of the local safety regulations, as well as Apotex’s Health and Safety policies, and Safe Work Procedures.
• Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance; Demonstrates strong and visible support of our values.
• Initiate Change Control Records for shelf life extensions/reductions, SOP’s as necessary.
• All other duties as assigned.

Additional Information
Experience : 4-10 years
Qualification : BSC. Degree or Diploma in a Life Sciences
Location : Delhi
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global QC Stability Data Analytics
End Date : 25th April, 2019

Apply as Clinical Research Associate at Apotex @ Click Here for more details

Post : Clinical Research Associate

Job Summary
Responsible for study management and execution of studies as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) best practices and regulatory requirements

Job Responsibilities
• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center’s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
• Assists with Protocol, ICF writing, Case Report and Assists with the preparation of screening and study documentation for data collection
• Assists with follow-up appointments of Subjects
• Assists as required in the receipt, dispensation and inventory of test articles
• Prepares the clinic for study conduct ensuring all furniture, supplies and equipment ready for screening/clinic activities
• Ensures clinic staff activities for compliance with protocol and SOPs
• Assists with the Collection, reviewing and summarizing of clinical data and compilation of the clinical report
• Assist with the distribution of test articles to subjects as delegated by the Study Coordinator
• Conducts activities related to the transfer of subject samples
• Responsible for initiation and completion of archival of clinic study raw data, documents and records.
• Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
• 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.

Candidate Profile
BSc/MSc/ B. Pharmacy / M. Pharmacy 1-2 years experience Preferable

Additional Information
Qualification : M.Pharm, M.Sc, B.Pharm, B.Sc
Experience : 1-2 years
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : BEC
End Date : 30th March, 2019

Require Auditor in Quality Research and Development at Apotex

Post : Auditor - Quality R&D

Job Description
• 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 : 20th March, 2019

Apply for Auditor in Quality Research and Development at Apotex

Post : Auditor - Quality R&D
Job Description
• 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 : 30th January, 2019

Requirre Research Scientist at Apotex @ Click here for more details

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 : Research Scientist-Bioanalytical

Job Description
• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre’s, Standard Operating Procedures and in a consistent manner consistent with current regulatory ( DCGI- CDSCO,TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations.
• Performs bioanalytical method development and validation for the quantification of drugs and metabolites.
• Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems.
• Sets-up and ensures calibration of analytical systems and maintains instrument systems in good working order.
• Documents all the work and results of all assignments as required.
• Assists in the preparation of lab reports.
• Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management.
• To receive the plasma samples from the clinic and ensure their proper storage until further assay
• To write and revise SOPs as per need and maintain awareness of and adherence to all current SOPs.
• To oversee the raw data compilation and their archiving after completion of final reports.
• Performs routine maintenance on Mass Spectrometers and associated HPLC equipment.
• Applies assay for the routine batch analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques.
• Performs additional related duties as assigned by Management

Candidate Profile
•  Minimum M.Sc. / M. Pharm / Ph.D
•  4 to 6 years of experience in Bioanalytical Laboratory.
•  Knowledge of computerized data acquisition systems.
•   Good knowledge of GLP requirements

Additional Information
Experience : 4-6 years
Qualification : M.Sc. / M. Pharm / Ph.D
Location :  Bangalore, KA
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 25th December, 2018