Validation & Qualification Specialist

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 67,000 - 100,000; Full time

Job summary

Xepa-Soul Pattinson (Malaysia) Sdn Bhd is seeking a Technical Executive II to support validation and qualification activities across pharmaceutical processing lines. You will assist sampling, testing coordination, and preparation of validation/qualification reports, ensuring cGMP compliance and proper documentation.

The role involves training technicians, coordinating sampling plans, maintaining labeling accuracy, and supporting change controls and continuous improvement projects on the shop

Qualifications

• Bachelor's degree in science, engineering or technical discipline is required.
• Minimum one year of experience in the pharmaceutical or related industry for Technical Executive II.
• Knowledge of cGMPs, pharmaceutical processing, validation and documentation is preferred.
• Experience in solid dosage, liquids, creams, ophthalmic manufacturing or packaging is preferred.
• Good interpersonal skills to interface with executives, technicians and shop floor personnel.
• Good written and verbal communication skills are preferred.
• Fast learner and resourcefulness are preferred.

Responsibilities

• Support validation and qualification activities for plants and technical services team by assisting sampling and inspection activities.
• Coordinate swab and rinse sampling training and evaluate training outcomes.
• Assist in revising Validation Master Plans for PV, CV and HTS for management review.
• Follow up with Production on schedules for planned validation activities.
• Ensure clear labelling of validation and qualification samples to prevent mix-ups.
• Support material evaluation activities by coordinating material samples for testing.
• Compile comparative quality evaluation reports between current and alternative material sources for management review.
• Provide data and documentation support during initiation of change control.
• Support training of shop floor personnel after validation activities.
• Assist in operation qualification and performance qualification of new equipment and packaging components.
• Provide technical support and gather information on technical areas as requested by Technical Services staff.
• Participate in continuous product and process improvement projects and other problem-solving activities.
• Assist in training and supervising technicians during validation sampling.
• Ensure timely technical support for new or existing projects.

Education

Bachelor Degree in Science, Engineering or Technical related discipline

Job description

Xepa-Soul Pattinson (Malaysia) Sdn Bhd is seeking a Technical Executive II to support validation and qualification activities across pharmaceutical processing lines. You will assist sampling, testing coordination, and preparation of validation/qualification reports, ensuring cGMP compliance and proper documentation.

The role involves training technicians, coordinating sampling plans, maintaining labeling accuracy, and supporting change controls and continuous improvement projects on the shop