SALAÑO, ASHLEIGH Y.

Address: 4th Floor, Flat Ak, Block 5, Edificio Iat Lai Jardim, Macao, Macau, SAR, China

Contact no: +853-63687240

E-mail Address: [email protected]

PROFILE:

A highly experienced in manufacturing of Food and Pharmaceuticals including Research, Product Testing, In – Process Control, Product Planning, Process Operations, Statistical Quality Control, Experimental Techniques, Product Development and Technical Documentation – gained through “hands on” training and laboratory experience. Ability to conduct detailed experiments and laboratory testing and interpret results, write protocols and report.

Experienced and trained in manufacturing and validation of sterile, tablet, capsule, soft gel, steroid, creams, ointments, solutions, syrups, liquid suspensions, powder for suspensions, beta-lactams, topical and cosmetics products.

CORE COMPETENCIES:

Equipment Validation
Utilities Validation
GMP
Process Validation
Technical Support
HACCP
Cleaning Validation
Quality Auditor
SAP
Analytical Method Validation
Product Development
Kaizen
Computer Validation
Documentation Management
Kanban
Facility Validation
Operations Management
Winlims
WORKING EXPERIENCES:

·         Ashford Laboratories Limited, Macau, SAR, China

Ø  Pharmaceutical Manufacturing Company

·         Validation Officer (January 2018 – present)

o    Job Description:

1.     Responsible for the validated state of the Manufacturing Plant.

2.     Identifies and prepare the validation documents that may need to be prepared or revised as a result of the validation.

3.     Prepares validation documents (protocol and reports) in accordance with the existing project standards and pertinent standard operating procedure, and adequately reflects the tasks and deliverables necessary for the validation.

4.     Coordinates and supervise the validation activities, tracks their progress and provides needed updates to the Technical Director.

5.     Ensures strict compliance to the approved protocol during the conduct of validation run, most especially during critical stages of the validation activity.

6.     Ensure that all validation/ qualification study will undergo sufficient assessment prior to conduct of the actual validation/ qualification activity.

7.     Aligns validation activities with audit findings to improve the overall quality and value of validation activities.

8.     Provides technical guidance in the conduct of validation activities.

9.     Refers to technical dossiers and international standards and strives to keep the Manufacturing Plant abreast with the latest validation standards/ strategies and best practices.

10.  Guides and supervise the Validation Team through the different stages, including collation, organization and presentation of data.

11.  Responsible for analyzing and assessing validation test results and making dispositions as deemed necessary.

12.  Performs risk assessment prior to validation activities.

13.  Prepare and revised master batch records which are deemed for validation.

14.  Conduct External Audits to the Material Suppliers (Raw and Packaging).

15.  Co-head with the Technical Director on the semi-annual internal audit with the IQA team.

·         Interphil Laboratory Inc., Cabuyao, Laguna, Philippines

Ø  Pharmaceutical Manufacturing Company

·         Validation Technologist (July, 2016 – January, 2018)

o    Job Description:

1.     Executes of annual environmental monitoring (air particle count, air flow verification and thermal mapping) in Plant 1 and Plant 2.

2.     Prepares the protocols necessary for the conduct of non – process qualification and validation activities (Equipment, Facility, Utility, Cleaning and Computer).

3.     Assists in preparatory activities, planning and coordination work at all levels with regard to the assigned validation task.

4.     Ensures validation activities are executed according to prescribed timelines and firm schedules.

5.     Supervises the conduct of the non – process validation activities (IQ/OQ).

6.     Implements the validation test requirements; and ensures that the qualification and validation activities are executed in compliance to pre – approved validation protocols, Standard Operating Procedures (SOP’s) and cGMP.

7.     Follows – up, collects reviews and analyzes validation data and analytical results.

8.     Analyzes all test results and prepares endorsements and verification/ validation reports.

9.     Performs contingent tasks related to or arising from the validation activity, such as but not limited to:

a.     Preparation of Deviation Reports, Change Notification Forms and Investigation Reports.

b.    Recommendation on revisions to SOP’s.

c.     Technical presentations to Validation Department or Technical Committee.

d.    Final turn – over to process owners.

10.      Maintains and updates Validation databases on non – process validation.

11.      Encodes diagrams, illustrations and communication letters, as needed, for non – process validation.

12.      As needed, provides technical support for queries from management on non – process validation activities.

13.      Provides assistance in the conduct of cleaning validation and manufacturing process validation activities, as the need arises.

14.      Performs other assignments which may be required from time to time.

·         Interphil Laboratory Inc., Cabuyao, Laguna, Philippines

Ø  Pharmaceutical Manufacturing Company

·         Validation Project Assistant (September, 2015 – July, 2016)

o    Job Description:

1.     Provides technical support and assistance for the conduct of both process and non-process validation activities.

2.     Prepares validation documents in support of the validation studies; such as, but not limited to protocols, reports, endorsements, deviation reports and change control documents.

3.     Conducts validation test requirements, as stipulated in the validation protocol.

4.     Supervises validation projects and coordinates with various service Departments, with guidance from managers of the Validation protocol.

5.     Gathers, collates and analyzes data generated from the validation projects.

6.     Assists in the monitoring and closing of change control documents and deviation reports.

7.     Assists in the execution of annual environmental monitoring (air particle count, air flow verification and thermal mapping).

8.     Assists in the collection, submission, safe keeping, and destruction of validation samples.

9.     Performs other assignments which may be required from time to time.

·         Grand Alpha International Corp., Calamba, Laguna, Philippines

Ø  Food Manufacturing Company

·         Quality Assurance Specialist (August, 2014 – September, 2015)

o    Job Description:

1.     Supervise personnel on the production and Quality department in implementing strict Good manufacturing practices and Standard Operating Procedures as predetermined in the Quality Systems Manual.

2.     Accept responsibility of training and preparing new employees for any Quality and production position as predetermined in Quality Systems Manual.

3.     Educate and instruct plant personnel in recommended quality control testing, equipment sanitation and general sanitation and housekeeping practices. Confirm these procedures are being maintained.

4.     Confirm that plant audit procedures are properly carried out and assigned work schedules are maintained.

5.     Assist in development of special department projects and work in conjunction with manager, quality assurance services.

6.     Evaluate and take corrective action when necessary with regard to product date coding and trade age management at all levels of product movement.

7.     Determine overall plant product quality by conducting and evaluating various product tests and tests related to ingredients and packaging.

8.     Function as an information source for Quality and other departments when critical quality issues arise.

9.     Resolve major quality problems at bottler production facilities, warehouses, and market areas as required.

10.      Consult with plant management and personnel on better operational procedures to improve overall efficiency and product yields.

11.      Discuss plant evaluation with plant management, make appropriate recommendations and set timetable for improvement and corrections.

12.      Prepare plant evaluation reports and submit them to manager, quality assurance Services.

·         Ginebra San Miguel Inc., Cabuyao, Laguna, Philippines

Ø  Liquor Manufacturing Company

·         Quality Assurance Analyst (June, 2012– August, 2014)

o    Job Description:

1.     Trains and Supervise bottling personnel before and after deployment inside the production area.

2.     Implements Standard Procedures as predetermined in Quality Systems Manual.

3.     Collates, reviews, and analyze all production data and laboratory test results for proper generation.

4.     Inspect and conduct Quality testing of Liquor by Physico-Chemical Analysis of in-process and finished goods.

5.     Inspect and conduct Microbiological Analysis of raw material, in-process liqour, and finished goods.

6.     Ensures, monitor and supervise that all activities are executed inside the production area complies with the approved Standard Operating Procedures, and Good Manufacturing Practices.

EDUCATION:

●      Tertiary Education

New Era University

Bachelor of Science Major in Biology – 2012

9 Central Avenue, New Era, Quezon City, Metro Manila, Philippines

●      Secondary Education

Sinait National High School – 2008

Ricudo, Sinait, Ilocos Sur, Philippines

PERSONAL DATA:

●      Nickname:        Ash/Shinju

●      Date of Birth:   December 15, 1991

●      Age:                 26

●      Place of Birth:  Sinait, Ilocos Sur, Philippines

●      Gender:            Male

●      Civil Status:     Single

●      Height:             5.8 ¼ feet

●      Weight:            57 kg.

●      Citizenship:      Filipino

●      Religion:          Iglesia Ni Cristo (Church of Christ)

I hereby certify that the above information is true and correct to the best of my knowledge and ability.

________________________

ASHLEIGH Y.SALAÑO