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Required Development Quality Assurance Executive in SeQuent Scientific Limited

 

patent

 

Clinical research courses

SeQuent Scientific Limited is a leading integrated pharmaceutical Company with a global footprint, operating in the domains of Animal Health (APIs and finished dosage formulations), Human Health (APIs) and Analytical Services Headquartered in Bangalore, India "SeQuent" has seven domestic manufacturing facility, one International facility in Polatli, Turkey and a State-of-the-art R&D centre with 120+ scientists driving innovation. Our manufacturing assets have approvals from global regulatory bodies including USFDA, EUGMP, WHO & TGA marking our sales presence in 82 countries.

Post : Development Quality Assurance Executive

Job Responsibilities & Required Skills 
Primary duties and responsibilities include:
Issuance and archival of following documents
* Lab note books and log books
* Change control, incident, Analytical lab investigation and CAPA numbers and timely closer
* Issuance of batch records
* Issuance of protocol and report numbers for validation and qualifications
* Co-ordination with global team
* Issuance of specification and test procedure number
* Document uploading and managing in global database
* Training records
2. Review and Approval of
* Specification and STP’s of Drug substances and Drug products
* Stability protocol and Reports of Drug substances and Drug products
* AMTE of Drug substances and Drug products
3. Providing support to different laboratories in preparation of standard operating procedures and guidelines.
4. Providing support in preparation /review of instrument qualification and validation protocols and its reports.
5. Providing and coordinating training programs on Laboratory Practices.
6. Member on internal Audit team.
7. Review and disposition of deviations, Quality incidents and OOS.

Candidate Profile     

  • Experience in development QA generic drug products for reg. market for 4+ years
  • Qualifications: M. Pharm/ M.Sc.
  • Should have proven expertise and understanding of ICH/FDA/EMEA guided dissolution, assay, impurity and content uniformity methods, including API, in-process control samples and finished products
  • Should be familiar with vendor qualification and audit process
  • Good understanding of GMP requirement during development and scale up
  • Good communication skills

Additional Information:
Experience: 4+ years
Qualification: M.Pharm/M.Sc

Location: Ambernath/Thane

Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 28th August, 2016

Apply at: machhindra.tuwar@sequent.in

Posted By
Machhindra Tuwar
Sequent

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