We are looking for individuals who bring innovative ideas, a willingness to challenge the status quo and a focus on delivering value and results. We also look for people who enjoy their work, want to grow with us, engage in our Responsibility commitments and make a difference for our company, our patients and our shareholders.
We offer opportunities across our R&D-Formulation & Development (Inj.):
We are having multiple openings for Injectables Unit.
Please find JOB Details below :
Position: Sr. Officer/Executive- GMP Documentation (R&D-Injectable)
Qualification: B. Pharm / B. Sc.
Experience: 3-7 Years
Job Description:
Note: candidate must have Injectable experience.
1. Responsible for self-hygiene.
2. Responsible for preparation Master BMR, BPR and document management.
3. Responsible for preparation and revision of SOP.
4. Responsible for handling of change Control, Deviation and Quality Risk management.
5. Responsible for co-ordination with different department like Regulatory affairs, Manufacturing, Warehouse, Quality Assurance, Quality control and Engineering etc. for execution of scale-up, exhibit batches etc.
6. Responsible for supporting Regulatory affairs department for ANDA submission and responding CMC query.
7. Responsible to impart training to all subordinates.
Position: Asst. Manager/Manager-Packaging Development (R&D-Injectable)
Qualification: Graduate Diploma in packaging- IIP regular / Distance & BSc/B.Pharm with Packaging experience in R&D
Experience: 6-15 Years
Job Description:
Note: candidate must have Injectable experience.
1. Characterization of innovator packaging samples for Ophthalmic and injectable products.
2. Preparation and approval of packaging components specifications and STP.
3. Development of primary and secondary packaging materials for Ophthalmic and Injectable product.
4. Preparation and approval of Master packaging records for Injectable and Ophthalmic.
5. Technical support for packaging related activities for the entire cross functional team like QC, QA, RA and PD for day to day activities.
6. Finalization of packaging configuration for EB batch packaging as per product requirement.
7. Preparation and arranging of the change parts as per product requirement.
8. Supporting to the labeling team for the regulatory submissions.
Position: Sr. Manager/AGM-Product Development (R&D-Injectable)
Qualification: B. Pharm/M. Pharm
Experience: 7-15 Years
Job Description:
1. Responsible for development related activities of all parenteral products.
2. Responsible for preparation and review of MFR and MPR for exhibit batch of parenteral products.
3. Responsible for co-ordination with different department like manufacturing, Quality assurance, Engineering etc. for execution of scale-up, exhibit batches etc.
4. Responsible for indenting the raw materials, RLD, Packaging Material and other items required for product development as well as exhibit batches.
5. Responsible for preparation as well as review of study protocol required for exhibit batch of parenteral products.
6. Responsible for review of specification like API, Excipients, In-process, Finished product, Shelf life etc. of parenteral products.
7. Responsible for review of specification of primary packaging material.
8. Responsible for review of BMR and BPR of Exhibit batch.
9. Responsible for supporting Regulatory affairs department for ANDA submission and responding CMC query.
10. Responsible for preparation and review of PDR and other necessary documents of parenteral products required for ANDA submission.
11. Responsible for preparation and review of SOP for product development.
12. Responsible for reviewing GMP related documents as applicable.
13. Activities other than the defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD's instruction and guidance.
Position: Sr. Executive/Asst. Manager-Pharmacokinetics (R&D-Injectable)
Qualification: B. Pharm/M. Pharm
Experience: 4-9 Years
Job Description:
1. To work in coordination with internal teams (Clinical, Formulation and Analytical) and CROs for smooth conduct of preclinical and clinical studies, either exploratory or submission studies, required to prove sameness of in-house product with reference product.
2. To review and provide inputs for preclinical and clinical study outline prepared by CROs in coordination with clinical teams.
3. To review and comment on draft protocols for conducting animal pharmacokinetics, tissue distribution, pharmacodynamics and toxicology studies for ophthalmic products and injectable.
4. To review and comment on draft protocols for conducting human bioequivalence studies (PK,PD, Efficacy) and other safety studies (eg. Immunogenicity studies) for ophthalmic products and injectable.
5. To review and comment on draft reports for animal and human studies listed above.
6. To collect, compile and analyze data generated from the above mentioned in vivo studies.
7. To collect, compile, analyze and correlate in vitro properties (physicochemical characteristics and in vitro drug release) with in vitro outcomes, and based on that provides inputs to formulation team for optimizing formulation for pivotal studies.
8. To perform an exploratory in vitro population bioequivalence statistics on particle size distribution data.
Interested candidate can share their CV on kavitriy@amnealindia.com
Regards
Kavitri Yadav
Human Resources
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