dgm qa in visakhapatnam

posted
job type
permanent
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job details

posted
location
visakhapatnam, andhra pradesh
job category
Pharma, healthcare & lifesciences
job type
permanent
experience
15 To 18
reference number
937551
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job description

- Review and approval of all master documents such as Standard operating procedure, operating instructions, Master Production Records, Validation protocols and others.
- Responsible for batch release of Drug Product (OSD) and Drug substance products.
- Review and approval of investigations of Market Complaints, Deviations and CAPA implementation
- Review and approval of TrackWise Change controls and impact assessment
- Responsible for conducting site level risk management activities.
- Coordinating site level quality management review meetings as secretariat
- Leading IPQA, Validation and Analytical Assurance teams of Drug Substance and Drug Product.
- Coordinating with functional heads of cross functional teams for stable supply of high quality products
- Conducts site level GMP and Data Integrity trainings to ensure the training program is implemented as per the schedule
- Responsible for review and approval of Product quality reviews
- Manpower planning and budgeting under the direction of Head Quality and Regulatory
- Responsible for Process Validations (PPQ), Cleaning validations and Continuous process verifications are conducted as per the VMP


Benefits
Salary Benefits
Brand Reputation

Client Introduction
Japanese MNC Based organization, manufacturer of Pharmaceuticals, API and formulations, R&D (API Generics)

skills

?API, Quality, CAPA,USFDA OSD

qualification

- Shall have experience of working in highly regulated environment with sound understanding on shop floor and quality control GMP.
- The candidate must have hands on experience of handling Quality teams with good review, training and auditing skills.
- Shall have sound understanding on latest cGMP regulations including GMP aspects of computer systems