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Responsibilities

Responsibilities

1. Conduct necessary and effective monitoring of all production activities and operations from material receipt to product dispatch, and maintain supervision records.
2. Review and supervise the handling or disposal of non-conforming products and status labels during production, and document accordingly.
3. Monitor personnel and material flow in production areas; conduct sampling of in-process products; and effectively inspect personnel movement, hygiene practices, and production order (including zoning management).
4. Inspect and supervise the implementation of all production documents, with a focus on Standard Operating Procedures (SOPs) and original operation records.
5. Inspect changing rooms, workwear (including uniforms, shoes, and caps) in production areas to ensure compliance with cleaning and changing standards.
6. Inspect the cleaning, usage of various containers, and the application of status identification cards.
7. Verify that production formulas, material weighing, equipment, and measuring instruments meet specified requirements.
8. Monitor and inspect environmental clean-up in production workshops; document the process; and issue Clean-up Pass/Fail certificates.
9. Responsible for sampling raw materials, packaging materials, and process water; ensuring sample representativeness.
10. Manage sampling environments and perform regular cleaning and maintenance of sampling rooms.
11. Complete all sampling records and maintenance logs.
12. Supervise and inspect warehouse storage conditions (including environmental hygiene, temperature & humidity) and status labeling (including "Sampled" tags).
13. Handle sample transfer and registration with the Quality Control (QC) department.
14. Complete ad-hoc tasks assigned by department leadership.
15. Inspect and monitor material consumption from herbal cleaning/preparation to bulk products.
16. Promptly report any abnormalities or deviations and implement measures to ensure product quality.
17. Complete ad-hoc tasks assigned by the immediate supervisor.
18. Assume full responsibility for safety within this position.

Responsibilities

1. Review, process, and submit Adverse Drug Reaction (ADR) data fed back from the National ADR Monitoring System; conduct data analysis and evaluation.
2. Perform signal detection and assessment; identify and evaluate drug safety risks, and propose risk control recommendations.
3. Conduct literature searches, downloads, and archiving to identify Individual Case Safety Reports (ICSRs) and other safety information.
4. Timely conduct follow-ups and handle Adverse Drug Reaction/Events.
5. Organize or assist in pharmacovigilance-related communication, education, and training activities.
6. Assist in establishing and maintaining channels for collecting and transmitting safety information; proactively collect and report ADRs/Events from independent sources such as the market front-line, academic literature, and the internet.
7. Participate in post-marketing drug safety studies.
8. Draft or review documents including Periodic Safety Update Reports (PSURs), Pharmacovigilance Plans, and Adverse Reaction Analysis Reports.
9. Assist in the operation and maintenance of the pharmacovigilance system; cooperate in internal audits and external inspections; promptly establish deviations and CAPA (Corrective and Preventive Actions).
10. Assist in drafting and revising pharmacovigilance department documents; ensure documents are effective and distributed to relevant departments; regularly review and update them to ensure standardized management of files and records; archive pharmacovigilance documentation.
11. Assist in the reporting, investigation, evaluation, and handling of major/emergency events such as individual ADRs, clustered events, or fatal cases.
12. Participate in major risk assessments, response to significant or urgent drug incidents, risk control decision-making, and other major pharmacovigilance-related matters.
13. Participate in Drug Safety Committee meetings and assist in the implementation of related activities.
14. Assist in updating safety information in drug package inserts (SmPCs).
15. Assist in the management of outsourced pharmacovigilance activities.
16. Take responsibility for safety within this position.
17. Perform other duties related to pharmacovigilance.

Responsibilities

1. Solution Preparation Operator: Operate in accordance with the Standard Operating Procedures (SOPs) of this position to compound qualified raw materials and excipients into finished pharmaceutical liquid as per the process formula.
2. Vial Handling Operator: Complete vial depalletizing, sorting, and feeding operations in strict compliance with the position management procedures and related SOPs, supplying vials for the washing process.
3. Vial Washing Operator: Strictly adhere to the position management procedures and related SOPs to wash ampoules/vials, ensuring the quality and quantity meet the requirements for the subsequent process.
4. Filling and Sealing Operator: Operate in strict accordance with the position SOPs to fill qualified pharmaceutical liquid into vials/ampoules as per process specifications, followed by sealing and transfer to sterilization.
5. Sterilization Operator: Perform operations strictly following the position management procedures and related SOPs to sterilize the filled and sealed products as per process requirements.
6. Visual Inspection Operator: Carry out light inspection tasks according to the position SOPs. Products must pass random sampling checks conducted by the on-site QA personnel before being released to the packaging process.
7. Packaging Operator: Strictly comply with relevant management procedures, SOPs, and specific operational guidelines for the packaging line. Prior to production, carefully verify the batch packaging instructions and confirm the area clearance status.
8. General: All the above positions are required to complete other tasks assigned by the workshop and assume full responsibility for safety within their respective positions.

Responsibilities

1. Strictly enforce management standards and technical standards established by this department and related departments, and conduct testing in accordance with various analytical procedures.
2. Responsible for the physicochemical testing of incoming raw materials, certain primary packaging materials, in-process products, and finished products to ensure accurate and reliable data.
3. Responsible for the periodic monitoring of potable water (specific parameters), purified water, and water for injection, ensuring data integrity and reliability.
4. Conduct stability studies on products according to the specified testing schedule for ongoing stability programs, ensuring accurate and reliable data.
5. Perform testing or method validation experiments on samples during the R&D phase and capable of drafting method validation/verification protocols.
6. Ensure the proper operation and maintenance of HPLC systems, precision instruments, and general analytical equipment.
7. Responsible for the preparation of various reagents, indicator solutions, and the standardization of volumetric solutions.
8. Oversee the daily management of various testing areas within the laboratory.
9. Assist in metrology, calibration, and qualification activities within the laboratory.
10. Assist the supervisor in drafting and revising various Standard Operating Procedures (SOPs).
11. Collect and organize various testing data for scientific analysis and evaluation, reporting findings to the immediate supervisor in a timely manner.
12. Collaborate in conducting thorough investigations and maintaining records for any Out-of-Specification (OOS) or anomalous results encountered during testing.
13. Responsible for the usage and daily management of the reagent store, including controlled precursors and highly toxic reagents.
14. Complete ad-hoc tasks assigned by the immediate supervisor.
15. Assume full responsibility for safety within this position.

Responsibilities

1. Organize relevant personnel to draft and review validation protocols; conduct pre-validation training for implementation teams.
2. Develop validation strategies and establish acceptance criteria for validation activities.
3. Select appropriate methodologies for validation execution.
4. Coordinate and communicate regarding assigned validation projects; develop implementation plans and supervise the execution of validation activities.
5. Collect relevant data and records during validation execution; analyze and summarize validation results.
6. Handle deviation analysis and resolution, as well as change control management arising during the validation process.
7. Draft validation master plans and annual validation summaries; manage the issuance of validation numbers and the archiving/retrieval of validation documentation.
8. Assume full responsibility for safety within this position.

Responsibilities

1. Operate in accordance with the Standard Operating Procedures (SOPs) to complete tasks related to the synthesis process.
2. Manage the fixed-position placement of materials and tools within this work area.
3. Complete other tasks assigned by the workshop.
4. Assume full responsibility for safety within this position.

Responsibilities

1. Strictly enforce management standards and technical standards established by this department and related departments; conduct testing in accordance with various analytical procedures.
2. Responsible for performing microbial limits testing or sterility testing on incoming raw materials, certain primary packaging materials, in-process products, and finished products to ensure accurate and reliable data.
3. Responsible for the periodic testing and monitoring of potable water, purified water, and water for injection.
4. Perform bacterial endotoxin testing on incoming raw materials, pharmaceutical water, and finished products to ensure data integrity.
5. Ensure the proper operation and maintenance of precision instruments, general analytical equipment, and related devices.
6. Responsible for the preparation, usage, and management of various reagents, indicator solutions, culture media, and test strains.
7. Oversee the cleaning, disinfection, and sterilization of instruments and equipment used in the Microbial Limits Room, Positive Control Room, and Sterility Room.
8. Conduct culture media suitability tests to ensure media complies with standard requirements prior to use.
9. Perform verification checks on standard reagents for endotoxin testing to ensure reagents meet specifications.
10. Responsible for the revival, sub-culturing, identification, and daily management of test microorganisms to ensure proper usage.
11. Conduct method verification for new projects or new analytical methods.
12. Perform periodic qualification and calibration of equipment used in microbiological testing.
13. Assist the department head in drafting and revising various Standard Operating Procedures (SOPs).
14. Collect and organize testing data for scientific analysis and evaluation, reporting findings to the immediate supervisor in a timely manner.
15. Complete ad-hoc tasks assigned by the immediate supervisor.
16. Assume full responsibility for safety within this position.

Responsibilities

1. Strictly enforce management standards and technical standards set by this department and related departments; conduct testing in accordance with various Standard Operating Procedures (SOPs).
2. Perform physicochemical testing on incoming raw materials, certain primary packaging materials, in-process products, and finished products to ensure accurate and reliable data.
3. Conduct periodic monitoring of potable water (specific parameters), purified water, and water for injection, ensuring data integrity.
4. Perform stability testing on products under continued stability studies according to the specified testing schedule.
5. Conduct testing or method validation experiments for certain samples during the R&D phase; capable of drafting method validation/verification protocols.
6. Assist in the metrology/calibration and qualification of laboratory instruments.
7. Ensure the proper operation and maintenance of HPLC systems, precision instruments, and general analytical equipment.
8. Responsible for the preparation and standardization of various reagents, indicator solutions, and titrants.
9. Manage the usage and daily inventory of reagents in the reagent store, including precursor chemicals and highly toxic reagents.
10. Oversee the daily management of various testing areas within the laboratory.
11. Assist the supervisor in drafting and revising various testing SOPs.
12. Collect and organize testing data for scientific analysis and evaluation, reporting findings to the immediate supervisor in a timely manner.
13. Collaborate on the investigation and documentation of Out-of-Specification (OOS) and Out-of-Trend (OOT) results during the testing process.
14. Complete ad-hoc tasks assigned by the immediate supervisor.
15. Assume full responsibility for safety within this position.

Responsibilities

1. Cleaning Operations: Perform cleaning tasks in non-clean areas and public areas of the cleanroom zone strictly in accordance with documented procedures.
2. Garment Management: Responsible for the washing, sterilization, collection, and distribution of non-cleanroom workwear, cleanroom garments, and work shoes as per standard protocols.
3. Equipment & Utensil Sanitization: Carry out the washing and sterilization of cleaning tools, towels, and specific周轉(zhuǎn) containers used within the workshop.
4. Documentation: Accurately complete and maintain all required records for this position in compliance with regulations.
5. Ad-hoc Tasks: Complete other duties assigned by the workshop supervisor.
6. Safety Compliance: Assume full responsibility for safety and hygiene within this role.