Alembic Pharmaceuticals, A leading Indian Pharma Company with Presence in around 100 Countries in World, Alembic is Having a Workforce of 8000 and 350 Scientists working on Different Projects
Alembic Pharma is Looking for a competent Dynamic Executive having Experience in QA & QC in a Formulation Facility.
Designation: Sr Executive CQA+QC
Location: Mumbai
Job Description:
Desired Profile:
- Candidate should have 3 – 4 yrs experience in the pharmaceutical formulation plant in QA/QC dept.
- Exposure to the preparation of various documents like SOPs – Annual product review, Change control.
- Deviation control, Handling Product Complaints, and other quality Assurance SOP’s.
- Basic Analytical knowledge of QC instruments, Review of AMV protocols and Report, Review of Analytical Specification, Method of Analysis and Raw data,
Key Responsibilities
- To acknowledge, log, and assess the received Market / FDA / Export Complaints. Further, Co-ordinate with respective manufacturing site/stakeholders for the Investigation report with CAPA plan.
- To log and assess the change control/deviation and incident and coordinate with respective stakeholders for their comments on the assessment part for deliverables. And ensure closure of the document after its execution.
- To visit at the manufacturing site for Joint Analysis and QC investigations.
- Review of COA’ before releasing in SAP of LL/TP products for dispatch. Coordination with R&D/LL/TP/SCM to resolve the identified quality issues in the existing products.
- Review of technology transfer documents (MMD, MPD, specification, analytical method,) received from R&D for new products. Transfer of TT documents to LL/TP sites.
- Review of documents received from LL/TP sites i.e. Site master file, process validation documents, change controls, deviations, annual product review, periodic quality reports, etc.
- To carry out annual quality products review for contract manufacturing site products.
- Review of Analytical Raw data as per the method of analysis.
- Review of Analytical Method Validation Protocols and Report before technology transferring the same to Manufacturing Site.
- Well versed with handling all the QC instruments like HPLC, GC, UV, FTIR, Dissolution / DT apparatus, etc.
- Handling, Review, and closure of observed OOS, OOT, and incidences at the site.
Qualification: B.Pharma
Experience: 1-6 Yrs
Salary: 2,00,000 to 6,00,000 INR(CTC/PA)
Contact Details:
talent@alembic.co.in, quality@alembic.co.in, qualityform@alembic.co.in
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