CQA Manager jobs in Maharashtra - Double HR Consultancy

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  • CQA Manager (Corporate Quality Assurance)/Should Have experience in Injectables and Formulation Plant in Pharma/Job Location Boisar/10 yrs and above Experience/

    Double HR Consultancy

    1. 10 - 15 yrs
    2. Maharashtra, Boisar, Palghar, Thane NA NA NA
    NA
    Rs 10,00,000 to 12,00,000 p.a.

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  • Job View 91 Views
  • Applicants Less than 5 Applicants
  • 2021-04-14 2021-10-14

Job Description

CQA Manager (Corporate Quality Assurance)/Should Have experience in Injectables and Formulation Plant in Pharma/Job Location Boisar/10 yrs and above Experience/

Should Have experience in Injectables and Formulation Plant in Pharma.

Responsible for driving continual improvement initiatives at all sites.

Supporting sites for being ready for audits and inspections. Face inspections for corporate related responsibilities.

Ensure that Quality systems are in sync with current regulations by sharing updated regulatory guidance to all PEL sites and provide training to sites on new regulations.

Updating sites about warning letters and ensure compliance against each observation across PEL sites.Provide guidance to sites on mapping and implementing CAPAs.

Handling projects which are strategic in nature such as QUEST, 24/7 Audit Readiness at sites, Data integrity Compliance etc.

Reviewing sites data on process capability ,OEE, Critical complaints ,deviations etc

Preparing and updating of Corporate Guidelines in lines with new regulations

Conduct audits at domestic and international sites.

Conduct monthly reviews with all sites. Coordinate and consolidate data for Management reviews.

QUALIFICATION: M. Pharm / B. Pharm / Masters in science EXPERIENCE: 10 -15 years on industry experience in GMP environment. Should Have experience in Injectables and Formulation Plant in Pharma.

Experience in GMP QA with technical expertise.

Should have worked in Corporate quality and should be well versed with roles and responsibilities of Corporate Quality Function. Should be well versed with requirements of management reviews.

Should be able to effectively consolidate and present site data to management using powerful presentation skills.

Sound knowledge of GMP regulations and guidelines (USFDA,EU,WHO etc).

Good communication skills (Verbal & written).

Adequate experience in handling data integrity audits. Aware about DI requirements and recent

Key Skills

  • Good Communication Skill
  • CQA Manager
  • Corporate Quality Assurance
  • Pharma Production
  • Pharma Quality Assurance

Industry

Pharma / BioTech / Clinical Research

Functional Area

Pharma / R&D / Biotech

Number of Vacancy

3

Qualification

B.Pharma, B.Sc, M.Pharma, M.Sc


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