Wockhardt is a true Indian Multi-National Company with a multi-ethnic workforce of 7500. Wockhardt Associates from 14 different nationalities globally. It has 3 research centers and 12 manufacturing plants, with businesses ranging from the manufacture and marketing of Pharmaceutical and Bio-pharmaceutical formulations, Active Pharmaceutical Ingredients (APIs) and Vaccines. The company has successfully created an integrated multi-technology capability to manufacture, ail types of dosage forms including sterile injectables and lyophilized products, Highly skilled technicians operate 12 manufacturing facilities that are US FDA, UK MHRA'and EMEA compliant sites in India, the US and Europe. To meet the challenges we need dynamic team members to take care of Machines & Products activities at Daman (Formulation Plant).
Post: Sr. Research Associate/Research Scientist
Job Description
JOB OBJECTIVE:
Experimental: Analytical method development, Analytical support to preformulation /in process support to formulation development, Execution of stability study, Method Validation, and Method Transfer to respective location for inhalation formulations like DPI, Nasal and MDI projects.
Characterization of Inhalation projects: Practical understanding of ACI, NGI, Dose uniformity sampling assembly, Spraytech, Spray view and Particle size analysis is essential
Documentation: Preparation and review of Standard Test Procedure, Method validation protocols, reports and Technical presentations.
Compliance: Good understanding of GMP, GDP and GLP
Regulatory: Good understanding of official monographs, ICH / CDER guidelines and other relevant papers and literatures.
KEY RESPONSIBILITY AREAS:
1. Analytical method development by HPLC
2. Expertise in handling of ACI, NGI, DUSA and Morphology
3. Characterization studies for nasal products like Spray content uniformity, Droplet and particle size distribution, Priming and repriming with tail off profile, spray pattern and plume geometry
4. Stability and in-process/routine support
5. Analytical method validation
6. Analytical Tech Transfer to plant location
EDUCATIONAL QUALIFICATION: M.Pharmacy (pharmaceutical/Analytical chemistry)
M.Sc. (Analytical/organic Chemistry)
MINIMUM RELEVANT EXPERIENCE REQUIRED: Three to eight years
LANGUAGE REQUIREMENTS (IF ANY): English
INTERNAL CUSTOMERS: Analytical Pharma Team
EXTERNAL CUSTOMERS: Formulation Development, RA, Compliance, QC and Support team
TRAVEL REQUIREMENTS: To Plant QC for method transfer/Support- Not frequent
JOB SPECIFIC COMPETENCIES:
1. Regulatory understanding of inhalation projects with good analytical skills
2. Setting up specification for inhalation projects
3. Good communicator
4. Believes to work in team
JOB COMPLEXITIES:
Timely execution of activities
Develop, trouble shoot and validate the methodologies for inhalation projects (DPI) characterization.
KEY MEASURES OF SUCCESS:
1.Timely completion of Analytical method development, validation and tech transfer.
2.Timely analytical support to formulation development for stability and in-process support.
Additional Information:
Location: Aurangabad
Experience: 2-4 Years
Qualification: M.Pharm, M.Sc
Functional Area: R&D
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Last date: 5th September, 2015
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