Technical Services Executive (Validation)

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

• To support smooth operation of validation and qualification activities in plants to Technical Services Unit Manager by providing technical support during sampling and inspection activities, follow-up of testing results, compilation of validation and qualification results and outcomes, and assist in preparation of validation and qualification reports.
• To provide swab and rinse sampling training to technician from cross-functional department and coordinate the training evaluation by performing recovery studies.
• To assist the revision and update of the Validation Master Plans for Process Validation (PV), Cleaning Validation (CV) and Product Hold Time Study (HTS) for management review and approval.
• To follow-up with Production for production schedules of planned validation and qualification activities.
• To ensure clear labelling of validation and qualification samples to prevent mix-up.
• To support the material evaluation activities by coordinating the material samples for physical and chemical testing.
• To compile the comparative quality evaluation report between current and alternative sources of materials for review by Technical Services Unit Manager.
• To provide data and documentation supports to Technical Services Executive I during initiation of change control.
• To support the training to production shop floor personnel after process validation, cleaning validation and performance qualification activities.
• To support in operation qualification and performance qualification of new processing and packaging equipment and execute the test run of samples for new packaging components.
• To provide technical support and collection of resourceful information on technical areas as requested by Technical Services Engineer I/ Executive I/ Pharmacist I.
• To participate and contribute during continuous product and process improvement projects and support other types of problem solving activities.
• To assist in training and supervising technicians in carrying out their duties during validation sampling.
• To ensure timely technical support to existing or new projects as assigned from time to time.
• To inform superior if detected any abnormality, deviation or anomaly condition during the execution of validation and qualification activities.
• Bachelor Degree in Science, Engineering or Technical related discipline.
• Minimum one (1) or more years of experience in the pharmaceutical or related industry for Technical Executive II.
• Possess knowledge of cGMP’s, pharmaceutical processing, process and equipment validation and documentation is preferred.
• Experience in one or more of the following areas: Solid dosage manufacturing, Liquids, Creams and Ophthalmic manufacturing and Packaging processes is preferred.
• Good interpersonal skills to interface with executives, technicians and shop floor personnel.
• Good communication skills, both written and verbal is preferred.
• Fast learner and resourcefulness is preferred.