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2 Facility Validation Jobs

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5.0 - 12.0 years

0 Lacs

chennai, tamil nadu

On-site

We are looking for an experienced Advanced Digital Manufacturing Specialist to be a part of our team. As an Advanced Digital Manufacturing Specialist, you will be instrumental in the implementation and enhancement of digital manufacturing technologies and processes within our organization. Collaborating closely with various teams, you will lead the digital transformation of our manufacturing operations to drive efficiency, reduce costs, and elevate the overall vehicle assembly process. Your responsibilities will include: - Validating BOM (Bill of Materials) - Writing assembly processes - Allocating parts station-wise and preparing scrolls - Implementing PFC/PFMEA (Process Failure Mode and Effects Analysis) - Developing control plans - Validating designs to ensure assembly feasibility - Standardizing fasteners - Implementing error-proofing and poke yoke techniques - Controlling part complexity - Ensuring seamless integration of design and manufacturing through simultaneous engineering - Establishing strong cross-functional alignment and negotiation skills - Validating tools, ensuring collision/interference prevention, facility validation, and conducting dynamic simulation studies - Proficiency in analytics, Excel, excel formulas, and Microsoft Office 365 - Preparing RFQs (Request for Quotation) with all technical aspects captured and facilitating a smooth handover to the industrial team Requirements: - Qualification: B-Tech/B.E. - Experience: 5 to 12 years Key competencies: a) Technical: - Proficient in assembly processes - Experience in executing at least one cycle of New Model End-to-End - Familiarity with CATIA and Teamcenter - Skilled in advanced/digital activities - Strong logical thinking abilities - Experience in RFQ preparations, negotiations with line builders, and tool design approval processes b) Behavioural: - Excellent communication skills - Leadership qualities to drive cross-functional teams - Strong analytical skills - Proactive and self-motivated - Team player with the ability to work within cross-functional teams to resolve quality issues - Effective problem-solving skills,

Posted 2 weeks ago

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5.0 - 10.0 years

0 Lacs

maharashtra

On-site

As a General Manager of Quality Assurance with 5-10 years of experience, your responsibilities will include validations and qualifications, preparation and implementation of the VMP & CMP, process validations, cleaning validation, and facility validation. You will also be in charge of equipment and instrument qualifications including URS, DQ, IQ, OQ, and PQ. Handling of deviations/incidences, internal quality audits, GMP audit system, annual product review, vendor audits, and qualifications are crucial aspects of this role. Your duties will also involve documentation, effective implementation of the document control system, preparation of Standard Operating Procedures (SOP), GMP & GLP records, and approval of Master Formula Records and batch manufacturing records. Quality control and stability studies will be under your supervision, and you should be fully conversant with the latest GLP requirements. Experience in handling sophisticated instruments like HPLC, GC, FTIR independently is required. Moreover, familiarity with ANDA and EU submissions, handling of regulatory deficiencies/queries work, preparation of Drug Master Files & dossiers for export markets are important responsibilities. Your expertise in ensuring compliance with quality standards and regulations will be essential in this role. If you are a detail-oriented professional with a solid background in quality assurance and a proven track record of successfully managing quality control processes and regulatory submissions, we encourage you to apply for this position.,

Posted 1 month ago

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