20/04 Bhavini Prajapati
HR Recruiter at Venus Consultancy

Views:128 Applications:1 Rec. Actions:Recruiter Actions:0

Executive - Regulatory Affairs/Quality Assurance - Pharmaceutical Firm (4-12 yrs)

Gujarat/Surat Job Code: 9775

Designation :- RA QA Manager

Location - Surat

Experience : 4 - 5 years 

Job Description :

- Be responsible for establishing in approved documents, maintain and continuously improve Quality System processes required by international, regional and national regulatory authorities and standards.

- Performs New Product Development (NPD) gate audits to ensure project deliverables adhere to governing processes, Review changes to existing products and SOPs to define the requirements for regulatory submissions.

Product Development QA RA.

- Provide quality and regulatory affairs input for the product development team and handle all QA & RA responsibilities through product development, design change and post market surveillance process.

- As part of core team, work with engineering team to ensure.

- Provide engineering and manufacturing with the relevant quality and regulatory affairs requirements that are part of Product Design Inputs for further product development.

- Product and Process Validation

- the establishment of product & process validation plans

- the appropriate execution and documentation of validation activities

- the review and approval of relevant documentation.

- Provide engineering and manufacturing with the relevant quality and regulatory affairs requirements that are part of product and process validation requirements

- Establish and analyse key performance indicators to evaluate and continuously improve the QMS

- Manage audits (internal and external) Requirements.

- Highly practical, hands on approach to quality system implementation, writing procedures, doing gap analysis with standards.

- Quality Engineering and Regulatory experience

- Excellent organizational and communication skills (including fluency in written and verbal English).

- Prior experience highly desired.

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