AKUMS DRUGS & PHARMACEUTICALS LTD is one of the most innovative, productive and research based pioneer organization of India having its registered office at Delhi and various plants in Haridwar, Uttrakhand giving employment to more than 2000 people. Akums is engaged in the manufacturing of tablets, capsules, injections, syrups on loan licensing and third party manufacturing basis. Akums is having certifications of WHO-GMP, ISO 9001, ISO14001:2004,NDA Uganda, PPB Kenya and complying USFDA , MHRA & other international standards.
POSTS:
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Research Associate/Sr Research Assoc - AR&D {below}
Post: Research Associate/Senior Research Associate - AR&D
Job Description:
1.Literature search for assigned projects.
2.Development of analytical methods.
3.Analysis of routine and stability samples following GLP and ensuring the accuracy of results.
4.Procurement of materials.
5.Preparation of Protocols and Reports.
6.Calibration of instruments and equipments as per schedule and preparation of report for same.
7.Execution of Analytical method validation & Analytical method transfer.
8.Maintaining calibration and qualification records of the equipments and instruments.
9.Online records in the laboratory note book
10.Costing of AR&D expenses
11.Online calculation and keeping raw data in file.
12.Knowledge on ICH guidelines, USP, EP & BP.
13.Entry of Instruments & column log books.
Candidate Profile:
M.Sc. in Analytical Chemistry or M.Pharm. in Medicinal Chemistry/ Pharmaceutical Chemistry/ Pharmaceutical Analysis. More than 60% marks in whole career. Chemistry & Mathematics should be compulsory in +2 Science. Post graduation from reputed institute is preferred. For M.Sc. candidates, chemistry should be Hons. in B.Sc.
1 to 4 years of relevant experience in Analytical Research & Development for ANDA projects mostly on US & European markets.
Excellent communication and interpersonal skill.
Proven ability to work creatively and think analytically. Should be fluent in English (written and oral).
Additional Information:
Exp: 1-4 years
Location: Haridwar
Education: B.Sc M.Sc, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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Research Scientist-AR&D
Job Description:
1.Individually handle the projects.
2.Analysis of Routine and stability samples.
3.Guide to juniors.
4.Interpretation of Stability study results.
5.Troubleshooting
6.Compilation of results.
7.Literature search for new projects.
8.Active participation in solving the regulatory queries
9.Responsible for Analytical method development of various dosage forms, solubility studies, Analytical Method Validation, Analytical Method Transfer etc.
10.Handling of deficiency letter queried by US FDA.
11.Preparation & Review of documents like SOPs, STPs for Raw materials, In-process and Finished products, AMVP and AMVR, Analytical method transfer protocols and reports, Study protocols and reports.
12.Should have thorough knowledge on ICH guidelines, USP, EP & BP.
13.IQ, OQ, PQ for new instruments
14.Calibration of Instruments and Equipments and review of reports.
15.Validation of Excel sheets.
Candidate Profile:
M.Sc in Analytical Chemistry or M.Pharm. in Medicinal Chemistry/ Pharmaceutical Chemistry/ Pharmaceutical Analysis. More than 60% marks in whole career. Chemistry & Mathematics should be compulsory in +2 Science. Post graduation from reputed institute is preferred. For M.Sc. candidates, chemistry should be Hons. in B.Sc.
4 to 6 years of relevant experience in Analytical Research & Development for ANDA projects mostly on US & European markets.
Excellent communication and interpersonal skill.
Proven ability to work creatively and think analytically. Should be fluent in English (written and oral).
Additional Information:
Exp: 1-6 years
Location: Haridwar
Education: M.Sc, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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Officer Stores
Job Description:
1.Handling inventory of various raw materials, packaging materials etc.
2.Maintaining the records and manual log books for the materials
3.Arranging and updating the stocks of materials at store as per their categories
4.Maintain cleanliness and order in the store
5.Perform other related duties as required
Candidate Profile:
B.Sc or equivalent degree. Candidate should have knowledge on inventory management system. Should have basic knowledge of Pharmaceutical raw materials like Active pharmaceutical ingredients, excipients, coating materials & Packaging materials.
Minimum of 3 yr of experiences in stores at formulation development Laboratories. Effective communication skills.
Excellent customer services and interpersonal skills, Bookkeeping skills, Computer skills including the ability to operate a cash register, computerized accounting, spreadsheet and word processing programs at a highly proficient level,
Time management skills.
Additional Information:
Exp: 3 years
Location: Haridwar
Education: B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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Sr.Officer / Executive - Packaging Development
Job Description:
1.Packaging Development for different dosage forms and testing and evaluation of packaging material of reference products. Develop packages which do not infringe any patents, are cost effective and novel.
2.Carry out machine trials with new materials and troubleshoot the problems. Initiate and carry out cost improvement projects.
3.Change Part Development, Keep abreast with the new technologies in this field.
4.Sourcing for new or innovative packaging material
5.Documentation, Issuance of specs., SOP’s and STP’s, and preparation of Master Packaging Records
6.Interact with R&D, AR&D, RA, marketing, and corporate medical services for development activity.
7.Development of primary, secondary, tertiary packing material, Ensure that the new pack is stable at different stages.
8.Handling of Projects (Cost reduction, standardization, automation etc.)
Candidate Profile:
B.Pharm, M.Pharm, B.Sc, M.sc; Experience in Pharmaceutical R&D packaging developmental activities for regulated markets. Should have knowledge of DMF/ANDA requirements.
2 - 5 years of experience in Pharmaceutical R&D packaging developmental activities for regulated markets.
Excellent verbal and written communication skill.
Shall co ordinate independently with internal as well as external customers.
Additional Information:
Exp: 2-5 years
Location: Haridwar
Education: B.Pharm, B.Sc, M.Sc, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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Executive/Sr.Executive-Drug Regulatory Affairs
Job Description:
1.Preparation of dossier in CTD, eCTD or ACTD formats for different regulated and semi-regulated market.
2.Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.
3.Ensuring effective and prompt attention and handling of queries from regulatory bodies of various countries.
4.Implement QA systems and generate SOPs.
5.Manage and facilitate all registration related activities.
6.Complete forms and requests originating from government agencies.
7.Ensuring preparation of documentation according to the requirements of regulatory body of the concerned country
8.Negotiating with regulatory authorities & obtain DCGI / local FDA approvals for marketing authorization. Update licensing and collect information on registration instructions and regulations.
Candidate Profile:
Master degree in Pharmacy or equivalents. Extensive knowledge and experiences in the regulatory field. Post graduate in diploma in regulatory affairs will be preferable.
4 - 7 years of experience in Drug Regulatory Affairs. Should have experience and exposure of regulatory submission for USFDA, TGA, MHRA, TPD etc.
Excellent verbal and written communication skill.
Keep up to date with market trends and new developments utilizing information for business improvement,
Careful planning to achieve accurate and timely results.
Additional Information:
Exp: 4-7 years
Location: Haridwar
Education: M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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Sr.Officer/Executive-Intellectual Property Rights
Job Description:
1.Preparation of Patent landscape and infringement analysis.
2.Basic knowledge of Patent laws of India, USA and Europe
3.Making Patent invalidation strategy
4.Knowledge of Patent drafting and filing procedure
Candidate Profile:
Master degree in pharmacy or equivalents. Preference will be given to candidate with specialized course in IPR and equivalent
Experience in Intellectual Property Management working for regulated markets, Should have experience on filing solid oral dosage forms for US and EU countries.
3 - 5 years of experience in Intellectual Property Management working for regulated markets
Excellent verbal and written communication skill.
Should have basic knowledge of Patent laws of India, USA and Europe. Should have knowledge of Patent drafting and filing procedure.
Additional Information:
Exp: 3-5years
Location: Haridwar
Education: M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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Sr.officer - DQA
Job Description:
1.Reviews or approves all R&D documents (i.e Formula and Procedures, Protocols and Reports, SOPs, R&D formats, Working Instructions, Operating Instructions and relevant forms for the R&D).
2.Supervises quality assurance activities of the R&D and TTD team and ensures compliance with GLP guidelines, other national and international guidelines and SOPs.
3.Reviews the ongoing stability data for support of proposed product shelf life as data becomes available, for submission batches.
4.Ensures that there is a program for approval and monitoring of contract manufacturers and contract facilities for R&D activities
5.Performs internal audits in the R&D as per the audit program and ensures corrective actions and implementation for the same.
6.Acts as QA representative for Technical Transfer between R&D and Production
Candidate Profile:
M Pharm in Quality Assurance or equivalent. GLP, GMP and GCP Auditing experience with intensive training in cGMP.
2 -3 years of experience in QA R&D. Should have experience in R&D pharmaceutical development, critical manufacturing concerns and deviations and justification for reanalysis and redevelopment.
Excellent communication and interpersonal skill.
Proven ability to work creatively and think analytically. Should be fluent in English (written and oral).
Additional Information:
Exp: 2-3 years
Location: Haridwar
Education: M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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Documentation Officer - AR&D
Job Description:
Preparation of SOPs, STPs, Analytical reports, Analytical validation documents, Calibration records of instruments, product stability reports and other relevant documents.
Candidate Profile:
B.Sc or equivalents. Experience in documentation of analytical development laboratories
Minimum 2 years of experience in documentation of analytical development laboratories.
Excellent verbal and written communication skill.
Well versed with Windows 98, 2000, XP & Vista, MS Office -2003 & 2007.
Good written & communication skills
Hard working & dedicated
Additional Information:
Exp: 2 years
Location: Haridwar
Education: B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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Sr.Research Associate - FR&D
Job Description:
1.Literature and FOI search for assigned projects
2.Formulation development of various dosage forms at R&D scale and perform compatibility study, optimization study, stability study etc
3.Perform the feasibility study, pre-formulation studies. Planning and executing pilot batches, pre-exhibit and exhibit batches as per the requirement of various regulatory market
4.Preparation of documents like SOPs, Master formula record, tentative specifications for in process and finished products, sampling protocols. Stability protocol and report, Product development report.
5.Testing of API physical properties, Innovator product characterization
6.Calibration and maintenance of log books of equipments with ensuring cleanliness of lab and equipments
Candidate Profile:
M. Pharm in Pharmaceutics or equivalent. 2-3 yrs of experiences in formulation development of solid oral dosage forms like tablets, capsules, pellets etc for regulated markets.
Excellent communication and interpersonal skill.
Should have basic knowledge of regulatory requirements for US and EU filing
Additional Information:
Exp: 2-3 years
Location: Haridwar
Education: M.Sc, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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LAST DATE: 20th June, 2012
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