Cephas Consultancy Services Private Limited has vacancies with the following details:

1) Industries

IT (Information Technology)

Corporate Finance/Accounting

Healthcare

Engineering

Data Science

Pharmaceuticals

E-commerce

Logistics/Supply Chain

Information Security

Human Resources

Banking/Financial Services/Insurance

2) Types of Companies

Fortune 500 companies

Forbes Global 2000 companies

Conglomerate companies

MNCs (Multinational Corporations)

Funded Startups

Local companies

3) Locations

India

USA

UK

Other European countries

Other Asian nations

Founded

2008

POSITION SUMMARY

This position is responsible for engineering functions within the Manufacturing Dept. The primary focuses are IQ OQ PQ activities and developing new strategies to exceed customer satisfaction. Implements and coordinates project progress, IQ OQ PQ validations, and statistical data analysis. Identifies and performs risk analysis to ensure inputs and outputs meet applicable medical validation and regulatory requirements. Position will have a high focus on internal R&D, project development, IQ OQ PQ validation SOPs Work Instructions and document approval. External focus is to ensure company success by identifying customer needs, customer expectations and meeting established completion dates.

ESSENTIAL FUNCTIONS

1. Interface with all departments to define validation project scope, responsibility, accountability, actions/functions, timelines, and goals.

2. Work closely with Quality and Regulatory Manager to develop project processes for IQ OQ PQ customer specific requirements, develop procedures, SOPs, protocols for project management.

3. Develop and manage validation master list activities to support IQ OQ PQ validations and qualifications as required. Prepare and perform process product qualifications as outlined in a customer specific validation protocol. Ensures project development and IQ OQ PQ practices meet FDA/medical regulatory requirements.

4. Work Instructions and IQ OQ PQ validation activities.

5. Streamline and manage IQ OQ PQ project process steps to ensure they are clear and concise; report on validation status and work with all departments to achieve IQ OQ PQ validations continuous progress, meet deadlines and exceed customer satisfaction.

6. Coordinate changes to IQ OQ PQ validation functions within all depts and customers.

7. Create/Write and circulate all protocols, SOPs, and Work Instructions to responsible departments (including customers & suppliers) including routing management signature of approval.

8. Provide input and output for validation testing to support product development; during R&D activities identify project risks that can affect form, fit, function and regulatory requirements for design, manufacturing, and quality.

9. Interface with quality dept to provide documentation, statistical process, validation methodology, and services to meet customer and regulatory requirements as directed.

10. Perform functions as directed to support quality management and company management team.

11. Support R&D efforts in molding and secondary operations

12. Work with R&D in transferring projects to manufacturing

13. Designing and developing manufacturing procedures, tooling, and fixtures that result in

sufficient capacity to meet customer demand while also promoting product quality, process

efficiency, and operator safety.

14. Providing production line support including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries.

15. Generating and modifying manufacturing process documentation and assuring that manufacturing processes and related documentation follow established policies and procedures.

16. Working with the Internal Audit team to perform annual schedule of quality system audits.

Supervisory Responsibilities

May supervise indirect reports and contract associates as needed.

POSITION QUALIFICATIONS

Education and Experience

1. A minimum of two-year degree in relevant field or equivalent required, with bachelor’s degree preferred, or applicable accredited certifications pertaining to job responsibilities.
2. Minimum of three years of manufacturing experience with project coordinator and IQ OQ PQ responsibilities preferably in a medical device (FDA21 CFR820 or ISO 13485:2016) environment. Pharmaceutical (21 CFR 210-211) environment experience will be considered.
3. Demonstrated knowledge of project coordination methodology and validation methods (IQ/OQ/PQ) statistical process control, application of statistical techniques, and meeting regulatory requirements per 21 CFR820/ISO 13485:2016.
4. Experience with Six Sigma, process capability statistics, AQL and background in medical device or pharmaceutical environment with FDA requirements strongly preferred.
5. Ability to effectively use statistics associated with ensuring product coordination and IQ OQ PQ functions.

All your information will be kept confidential according to EEO guidelines.