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Asst General Manager CQA - Pharma ( TP / LL ), Mumbai.

15.00 to 20.00 Years   Mumbai City   16 Mar, 2022
HRDHouse
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    Roles and Responsibilities1. Candidate should have handled Plan and perform vendor/ third party/ loan license/ warehouse audit and Monitoring of all the third party and loan license products.2. Candidate have experience in Review and approval of master documents, BMR, BPR, RMS, PMS, FPS and MOA. Review and approval of change controls, deviations, SOPs, destruction certificates.3. Candidate will be responsible for handling Preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.4. Candidate should be a Liaise with production planning, purchase, export, logistic, distribution, and registration department to achieve the production/ dossier submission targets.5. Candidate should be handling Provide support to analytical team for analysis of raw materials and finished products.6. Candidate should be handling audits such as TGA, UK MHRA, EU, PICS, MCA etc.7. Candidate should be handling GMP/ GLP/ FSSAI guidelines, knowledge on current CFR-21 (part 11) / GAMP5 / other technical data related guidelines, Should have hands on knowledge of SAP.Desired Candidate Profile1. Candidate should be M Pharm with 15 years experience in pharma CQA third party and loan license products.2. Candidate will be responsible for handling audits such as TGA, UK MHRA, EU, PICS, MCA.3. Candidate will be responsible for Plan and perform vendor/ third party/ loan license/ warehouse audits.4. Candidate will be responsible for Monitoring of Batch Release process for domestic as well as all export products.5. Candidate will be responsible for GMP/ GLP/ FSSAI guidelines, knowledge on current CFR-21 (part 11) / GAMP5 / other technical data related guidelines, Should have hands on knowledge of SAP.,

Keyskills :
raw materialsanalysislogisticspmsplanningbprproduction planningbatch release

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