Add office photos
Engaged Employer
i
This company page is being actively managed by
Apotex Research Team. If you also belong to the team, you
can get access from
here
Apotex Research
Compare
All Filters
4 Apotex Research Research Scientist Jobs
Research Scientist, Analytical Development
3-4 years
₹ 3.5 - 6.8L/yr (AmbitionBox estimate)
This is an estimate of the average salary range for this
position. It has not been reviewed by the company, and
the actual salary may differ.
Bangalore / Bengaluru
1 vacancy
Research Scientist, Analytical Development
Apotex Research
posted 15d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Job Summary
- Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements.
- Review of laboratory data, instrument logbook and reports wherever applicable.
- Initiation of departmental CCRs and tracking the progress to execute the proposed changes through QMS system.
- Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites.
- Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation.
Job Responsibilities
- Prepares working plan for assigned projects and provides timeline to Deputy Manager.
- Develops stability indicative analytical methods for drug substance and finished product
- Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems.
- Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters.
- Ensures analytical methods validation is conducted according to approved validation protocol in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines.
- Responsible for method verifications and publishing of analytical methods
- Maintenance and archival of analytical method validation documents.
- Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation.
- Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution.
- Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing.
- Conducts other tests required for dosage submissions.
- Conducts lab investigations for OOS and OOT results.
- Raising Change control for various analytical activities (Method SOP and department SOPs)by QMS trackwise
- To prepare General, Operation and Calibration Standard Operating Procedures.
- Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable.
- Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor.
- Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes.
- With guidance of scientists, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products.
- To participate in the mandatory trainings to execute the day to day job responsibilities.
- Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time.
- Practice and up-gradation of knowledge with respect to cGMP.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements.
- Ensures all instruments assigned with responsibility within group/department are well maintained.
- Work as a member of a team to achieve all outcomes.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
Job Requirements
- Education
- A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
- Knowledge, Skills and Abilities
- knowledge of the instrumentation such as HPLC, GC, spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques.
- Knowledge in HPLC method development and method validation.
- Knowledge on preparation and review of various documents like SOPs, Formats, Protocols, Reports, analytical data, investigation and deviation reports.
- Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities
- Should possess troubleshooting knowledge on Instruments and analysis.
- Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems.
- Working knowledge of LIMS is an asset.
- Good written and verbal English communication skills.
- Experience
- BSc with 5 years or MSc with 3-4 years experience in a pharmaceutical lab in an R&D environment.
- Chromatographic method development and validation.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
Employment Type: Full Time, Permanent
Read full job descriptionApotex Research Interview Questions & Tips
Prepare for Apotex Research Research Scientist roles with real interview advice
People are getting interviews at Apotex Research through
People are getting interviews through
(based on 18 Apotex Research interviews)
Referral
Company Website
Recruitment Consultant
Campus Placement
Walkin
Job Portal
11%
11%
11%
6%
6%
6%
49% candidates got the interview through other sources.
High
Confidence
?
High Confidence means the data is based on a large number of responses received from the candidates.
What Research Scientist at Apotex Research are saying
Rating based on 28 Research Scientist
reviews
Anonymous · Pharmaceutical & Biotechnology
in Bengaluru
Likes
Nothing is good
Dislikes
Work culture is too bad
Read 28 reviewsResearch Scientist salary at Apotex Research
reported by
52
employees
with 2-6
years exp.
₹3
L/yr - ₹6.9
L/yr
43%
less
than the average Research Scientist Salary in India
View more details
What Apotex Research employees are saying about work life
based on 766 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Apotex Research Benefits
View more benefits
Compare Apotex Research with
Sun Pharmaceutical Industries
Compare
Cipla
Compare
DRJ & CO
Compare
Biocon Limited
Compare
Glenmark Pharmaceuticals
Compare
Torrent Pharmaceuticals
Compare
Lupin
Compare
Zydus Lifesciences
Compare
Aurobindo Pharma
Compare
DIVI'S Laboratories
Compare
Abbott
Compare
Novartis
Compare
Sanofi
Compare
Merck
Compare
AstraZeneca
Compare
PPD
Compare
Novo Nordisk
Compare
Eli Lilly and Company
Compare
Astellas Pharma
Compare
West Pharmaceutical Services
Compare
Similar Jobs for you
Research Scientist (Formulation Development)
2-5 Yrs
₹ 4 - 7L/yr
Bangalore Rural, Bangalore / Bengaluru
Share an Interview