Implementation Specialist 3

Sanmina; Seberang Perai; On-site; MYR 120,000 - 170,000; Full time

Job summary

Sanmina Corporation in Malaysia is seeking a Validation Manager to oversee validation activities for medical customer accounts. You will ensure execution and review of tester protocols, Master Validation Plans, and related documents.

The role requires degree in Engineering or Science, at least 3 years of validation management experience in medical/pharma, deep GMP knowledge, and strong technical writing and communication skills.

Qualifications

• Degree in Engineering or Science.
• Minimum 3 years of validation management experience in medical/pharma.
• Strong knowledge of GMPs and validation; hands-on validation experience.
• Excellent technical writing and communication skills; strong problem solving.

Responsibilities

• Manage validation activities to ensure execution and review of tester protocol/test report and Master Validation Plan.
• Review execution of process/tester validations, re-validations, re-qualifications for on-site projects.
• Coordinate cross-functional teams to ensure accurate and timely execution.
• Approve validation documentation in a timely manner.
• Provide technical expertise on manufacturing processes and validation matters.

Skills

Validation management

GMP knowledge

Technical writing

Communication

Problem solving

Education

Degree in Engineering/Science

Job description

Description

Job Description: Manage Validation activities to ensure execution and review of tester protocol/test report and Master Validation Plan is conducted for medical customer account Review execution of process/tester validations, re-validations, re-qualifications any on-site projects. Manage all of the relevant parties cross functionally to ensure accurate and timely execution. Manage to review and execute validation protocols and test report and ensure that are technically correct and comply with internal and external requirement. Participate in the coordination of efforts of multi-disciplined project team on the writing, performance, documentation and approvals of validation lifecycle documentations. Manage approval of validation documentation by internal and customer on a timely basis. Manage protocols are executed as intended accordingly to the study plan/approach of process and test challenge test. Capable to provide technical expertise on manufacturing processes and validation related matter. Qualifications Required: (Education, experience, skills, etc. Please be specific) Â Â Â Â Â Â Â Â Â Â 1. Degree in Engineering / Science. 2. At least 3 years Validation Management experience ideally within the medical or pharmaceutical industry. 3. In depth knowledge of GMPs and validation. Hands on working experience on validation. 4. Good technical writing skill and communication skill is a must. Strong problem solving skills