Roles and Responsibilities
- To ensure implementation of appropriate quality systems for developmental activities in Synthesis and analytical dept.
- To review development documents for Regulatory submissions, including analytical method development/validation protocols and reports, product development reports, stability protocols and reports
- Thorough understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents; familiarity with GLP and GCP regulations
- To prepare and review SOP as per GLP requirement for analytical & synthesis dept.
- To provide guidance, oversight, and direction to external partners to ensure development activities are performed in a manner compliant with regulatory expectations.
- Experience to review and control analytical related documents
- To bridge between QA and R&D in terms of compliance as per regulatory requirements
- Vendor assessment report preparation and tentative vendor qualification report review and approval for new KSM’s.
- To ensure the compliance of technology transfer relevant activities
- Proposed specifications review and approval.
- Analytical method development data review and approval.
- Specification and Standard test procedures.
- Cleaning test procedures.
- Should have knowledge on Change controls, Out of trend (OOT), Out of specification (OOS), Incident, Deviation and regulatory deficiencies.
Desired Candidate Profile
Position: Executive / Senior Executive -DQA
Location: Ankleshwar, Gujarat
DQA experience is at least 5 yrs in R&D or ARD or QA.
Only DQA experience: 5+ yrs
Department: Developmental QA
Qualification: M.Pharm / M. Sc. / Ph.D. in organic / Analytical chemistry
Salary: As per Market standards
NP: 15 to 30 days
Salary: Not Disclosed by Recruiter
Role Category:Quality Assurance & Quality Control-Compliance & Regulatory
Role:Quality Assurance & Quality Control-Executive
Desired Candidate Profile
PG:M.Pharma - Any Specialization, MS/M.Sc(Science) - Chemistry, Chemical Engineering & Materials Science, Biotechnology, Bio-Chemistry, Organic Chemistry, Microbiology
ZCL CHEMICALS LTD
Dear Candidate :
We are USFDA, WHO GMP, ISO 9001, ISO 14001 and OHSAS 18001 certified Company. ZCL Chemicals Ltd.(formerly known as Zandu Chemicals Ltd.) was founded in 1991.
ZCL is engaged in manufacturing Chemical Intermediates and Active Ingredients for Pharmaceutical companies. It is a 100% Export Oriented Unit (EOU) that combines the power of science and technology. The company is headquartered in Mumbai and has clients across the globe. The R&D Center and cGMP- manufacturing facility is in the Industrial heart of Ankleshwar city in Gujarat. The Company delivers a broad range of advanced fine chemical intermediates and active ingredients for pharmaceutical end use and services to customers around the world. Custom synthesis, Long term contractual manufacturing under secrecy, Exclusive manufacturing under CDA, Contract Research work from milligram to kilo scale. ZCL is known for tailor-made the products to solve the challenges of customers.
We are looking for passionate team members to contribute and achieve individual and organizational success. you can also send your profile to email@example.com