Officer / Executive - Development Quality Assurance (DQA)

Officer / Executive - Development Quality Assurance (DQA)

5 Nos.
125993
Full Time
3.0 Year(s) To 6.0 Year(s)
3.00 LPA TO 4.50 LPA
Engg Design / R&D / Product Mgt
Chemicals/PetroChemical
B.Sc - Chemistry; M.Sc / MS Science - Chemistry
Job Description:

Qualification & Experience

  • M.Pharm / M.S / B.S in Chemistry, Pharmaceutics or related discipline
  • 3–5 years of experience in R&D (DQA)
  • Strong knowledge of GMP, GCP, GLP and 21 CFR 210/211
  • Experience with dermatology products or medical devices is an advantage

Key Responsibilities

  • Review development documents, analytical methods, R&D trials, lab notes, PDR, MFR, and batch records
  • Maintain R&D documentation and activities as per cGMP and GDP
  • Develop, implement and manage QMS elements (SOPs, Change Control, Deviations, CAPA, Complaints, etc.)
  • Support equipment qualification (DQ, IQ, OQ, PQ)
  • Tech transfer from R&D to pilot and production, including scale-up and optimization
  • Coordinate with R&D and Plant for batch execution and documentation
  • Responsible for process scale up & Optimization studies from R&D to Pilot and then to production scale.
Key Skills :
Company Profile

--- --- is an independent --- driven company specialized in the custom synthesis of pharmacopeial & non-pharmacopeial reference standards, drug glucuronides, drug metabolites, Isotope labelled reference standards and focused compound libraries. As a ----driven organization, we have developed novel processes to make niche products required to pharmaceutical companies globally at various platform. We understand the industry --- needs thoroughly and have earned reputation for being most reliable innovator of pharmaceutical reference standards worldwide.

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