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Sterling Life Sciences, Specialists in Pharmaceuticals, Healthcare and BioTech Recruitment
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Assistant Manager, Production

Location Job Id#
East Coast, USA 03270
About our client
Our client is a specialty oral drug delivery systems company that develops, commercializes and manufactures pharmaceutical products. The company has five commercialized oral drug delivery technology platforms and seven commercialized encapsulation processes.
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Maintain and follow cGMP practices and OSHA regulations
2) Prepare SOPs for production and process control designed to ensure that the drug products have identity, strength, quality and purity approved by QA
3) Ensure that compounding and storage containers, processing lines and major equipment used during the production of batch are properly identified and noted down in the batch manufacturing records
4) Document any deviations in written procedures and process control at the time of performance and justified as per SOPs
5) Ensure that the materials used in batch are released by quality assurance
6) Wear clean clothing such as protective apparel, head, face and arm coverings to protect drug products from contamination
7) Ensure that weights or measures are correct as stated in batch manufacturing, processing, packaging or holding of the drug product
8) Maintain batch uniformity and integrity of drug product with established in- process controls and tests
9) Ensure completion of each phase of production shall be established to maintain the quality of the product
10) Practice good sanitation and health habits
11) Oversee blending/mixing of actives and excipients for making solid dosage forms
12) Oversee making the tablets by using sophisticated instruments
13) Supervise film coating of tablets, capsule filling, packaging of dosage forms
14) Evaluate and modify existing processes as part of continuous improvement
15) Conduct process validation equipment qualification
16) Participate on technical team to justify, specify and start up new processes
17) Ensure that the reading of USP water system, temperature and relative humidity on chart records in production department are with in the specified limits
Requirements
1) Bachelor’s degree in Science
2) 2 – 5 years of working experience in pharmaceutical manufacturing operations
3) Knowledge of cGMP, quality systems and other FDA regulatory guidelines for drugs

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