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Shalina Healthcare
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Deputy General Manager - Quality

Deputy General Manager - Quality

Shalina Healthcare

18 - 25 years

0 Lacs

navi mumbai maharashtra india

Posted:1 day ago| Platform: Foundit logo

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Skills Required

cgmp cglp vendor management investigation quality agreements documentation practices capa

Work Mode

On-site

Job Type

Full Time

Job Description

What you become a part of:
Deputy General Manager Quality To lead the team of quality professionals in CQA to review and approve documents, investigations, market complaints, CAPA, gap assessments, vendor management, technical trainings and support Inhouse sites for compliance etc. Ensure/comply with Shalina QMS systems in compliance with internal and regulatory requirementsWhat to expect:

Review and approve change controls initiated by plants.
Review and approve vendor qualification documents and ensure effective implementation of the vendor approval system.
Monitor and ensure that all plants comply with cGMP, cGLP requirements and good documentation practices.
Support to manufacturing site for investigation and regulatory audit compliance.
Review and approve of CQA guidelines. Ensure that the CQA guidelines are in line with the regulatory requirement.
Review and approve SOP of Corporate departments.
Review and approve of change controls, deviations, protocols and reports, qualification documents, stability protocols and MFR/MPR of corporate department.
Review and approval of relevant R&D documentation.
Ensure quality agreements are in place with vendors, as per requirements.
Ensure that detailed investigations are in place for out of specifications, market complaints, product recall, and stability failures and that appropriate CAPA is planned and executed as per the defined procedures.
Ensure that all team members are trained and updated in line with regulatory requirements.
Effective implementation of training policy.
Ensure smooth transfer of technology for product transfers from one site to another.

Essential qualifications, experience, and skills:

B.Pharm, M.Pharm or MS / M.Sc with 18 to 25 years of experience in QA & CQA (with 10 to 15 years experience in manufacturing plant)
Should have adequate experience of facing various regulatory Inspections like SAHPRA (MCC), PICS, EU, NAFDAC, PPB etc.
Experience of working in Formulation unit.
Very good functional knowledge and application.
Managing multiple stakeholders.
Should hold high standards of business ethics
Strong leadership and team management skills, analytical and problem-solving abilities, and excellent communication and interpersonal skills

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Deputy General Manager - Quality