InvaGen Pharmaceuticals, Inc., an associate company HETERO GROUP, INDIA is a fast growing gener pharmaceutical company located in Long Island, Ne York, USA. Our core business is in the areas of Produ Development, Manufacturing, Marketing a Distribution of high quality and cost-effective gen prescription medicines. InvaGen has drug product development and commercial operations at three different facilities in Hauppauge, NY.
To strengthen its Manufacturing Operations " InvaGen " is looking for the dynamic and result oriented PHARMA PROFESSIONALS to be based at its finished dosages facility located in Long Island, New York, USA.
Posts: Analytical Development / Quality Control (Research Scientist(s) /Sr. Scientists), Sr. QA Associate / Asst. Manager / Manager, Sr. Regulatory Associate, Manufacturing Supervisor, Manager- Process Development & Technology Transfer
Analytical Development / Quality Control (Research Scientist(s) /Sr. Scientists) :
Responsible to develop and validate the analytical test method/procedure for API's and finished dosage forms as per FDA/ICH requirements. Responsible to perform stability analysis (HPLC, UV, GC) and supports formulation using dissolution testing or drug release studies. Responsible to provide technical support and testing to product development by conducting a variety of tests under minimal supervision including HPLC, dissolution, UV and GC, Develop,validate and troubleshoot analytical methods.
Responsible to test and analyze RM/PM, in-process samples and products such as APIs, solid oral finished dosage forms to determine stability, purity, chemical content and other characteristics.Able to perform calibration of QC instruments.
Qualification & Experience: Master degree in a scientific discipline combined with 5-10 years pharmaceutical experience of analytical techniques/instrumentation and USR FDA/ICH requirements.
Sr. QA Associate / Asst. Manager / Manager:
Knowledgeable in QA Manufacturing/Analytical Assurance activities. Able to perform in process checks for Tablets and Capsules; sampling of intermediates and finished products and possess thorough knowledge of interdepartmental aspects. Familiar with Facility & Equipment qualification, Complaint handling, Change controls, CAPA controls and Auditing techniques.
Qualification & Experience:
M.Pharm / M.Sc with 5-10 years of experience in IPQA, Mfg. /Analytical documentation review, Validation and exposure to International audits are essential.
Sr. Regulatory Associate:
Responsible to write.critical review, evaluate, compile and publish FDA submissions (ANDAs, amendments, supplements, annual reports and additional documentation,as needed) in eCTD format. Responsible for development of product labeling, including package inserts and container labels, Medication Guides, for the review, approval, tracking and archiving and submission. Responsible for reviewing CMC data for adequacy and conformance to regulatory requirements.
Qualification & Experience:
M.Pharm or M.Sc in Chemistry with 5 years of experience of ANDA filings and other regulatory submissions with USFDA is required.
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Manufacturing Supervisor:
Coordinates and supervises the daily activities of manufacturing of pharmaceutical solid dosage forms like Tablets, Capsules, etc. Assures efficiency in the manufacturing process and completes associated documentation, ensure effective implementation of quality management system as per cGMP and regulatory requirement (USFDA) at all levels during execution of commercial .validation and exhibit (ANDA) batches.
Qualification & Experience:
M.Pharm / M.Sc with 5-10 years of experience in IPQA,BMR Review & documentation, Knowledge of various Mfg. Equipments and exposure to FDA audits are esse ntial.
Manager- Process Development & Technology Transfer:
Collaborate with R&D in process development of solid oral dosage forms and undertakes identification of critical process parameters for successful technology transfer to Manufacturing. In-depth knowledge on all related equipment and processes involved in solid oral dosage forms is required.
Qualification & Experience:
M.Pharm with 5-10 years of working experience in Process Development & Technology Transfer group in a reputed Pharma Company with exposure to FDA audits are essential.
All eligible candidates should have strong communication skills, work independently or as part of team and possess good documentation practices.
Candidates meeting the above requirements may forward their resume by April 20, 2012 mentioning the position applied for in the subject line to hr@invagen.com and careers.usa@heterodrugs.com
Interested Candidates should be available for interview during the 1st and / 2nd week of May, 2012 at Hyderabad.
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