RESEARCH AND DEVELOPMENT SPECIALIST

Salary not specified

CARMONA, CAVITE
COLLEGE GRADUATE
Permanent

Job Description

Position Summary:

The R&D Specialist supports and gives assistance to the R&D Team and collaborate with her/his co-worker on all products developed and formulated products, performance of daily R&D activities, maintains and monitor all documents related to the R&D processes.

Job Scope:

Assists in the research and development of new products and protocols
Material Qualification and Accreditation
Product Costing
Perform SAP (Systems Application Product) transactions as required to support SBUs directly linked to R&D processes
Consolidation and safe-keeping of researches and related studies
Re-formulation of products and redirection of manufacturing processes as needed
Generation/ Preservation and Revision (if needed) of Master Production Documents
Trouble Shooting of problems regarding materials, processes, products and other related activities


Duties & Responsibilities:

In-charge of the manufacturing process trouble-shooting activities such as but not limited to:

Re-processing with advance under-studies product formula and recommends        pertinent percentage inclusion level to the original formulation for commercial process manufacturing
Ensures that the following parameters are satisfied within the covered monitoring:
Chemical analysis recovery is within the specified requirement
Physical and testing conformity
Commercial batching conform the re-processing guide;
Stability, if necessary
Compilation of test result/s and monitoring intact
Perform the SAP (Systems Application Product) transactions required for raw material reservation/requisition for developmental products and trial batches
Conducts study, review and pre-qualification of alternative source/s of applicable raw material substitution to existing component in the product formulation/s as a resolution to the identified trouble-shooting made and recommends accordingly
Performs research activities, the collation and orderly safe-keeping of the researched data information, hand-outs, or related dossiers that supports the commercial trouble-shooting or the recommended product enhancement or fortification of the existing product formula
Conducts supporting trial testing parallel to the commercially-identified trouble to rule out root-cause and recommends appropriate corrective actions/ Support on answering and investigation on product complaint
Prepares Master Production Documentation of all Re-processing formulation and the applicable registration to the Document Control Center (DCC)
Conducts pilot scale and production scale batch trials and technology transfer for new products developed
Plays vital role for the developmental project’s first three (3) commercial process validation protocol run and the applicable documentation and change control
Responsible for preparing the documents required by Regulatory for Product Registration
SOP Creation and Revision if needed
Collation and Preparation of Product Quality Review
Responsible for the updating of file record of the Master Batch Production Record (MBPR) and assures the complete attachment of the relevant supporting documents of the product dossier per envelope
Responsible for the requisition of the office and laboratory supplies pertinent to the department’s activities
In-charge of the Monthly Developmental Progress Reporting and the need to call for any related coordination meeting with the manufacturing related departments
Ensures safe-keeping and the corresponding inventory management of glass wares and RPDD Laboratory Equipment plus its preventive maintenance and calibration requirements
Authorized signatory for the following documents in the absence of the RDD Manager such as: Product Label, Costing Approval, MBPR/MPDR or its BPR/PDR approval, and any Raw/Packaging Material’s accreditation
Represents the Department for scheduled and unscheduled meetings and other technical presentation/ trainings or suppliers’ product presentation in the absence of R&D Manager

Qualifications/Requirements

Preferably a graduate of B.S. Chemistry, B.S. Chemical Engineering, B.S. Pharmacy, Industrial Pharmacy Other science related courses may also apply but with 2 years relevant R&D experience on Pharmaceutical and Veterinary Industry A professional board license would be an advantage.

Skills: Basic knowledge of computer operations and softwares, cGMP and ISO principles and implementation

Other: Must be responsible, hardworking, analytical, resourceful, result oriented, honest and trustworthy. Must be pro-active and adapts to all types of situation and personalities. Above average oral and written communication skills. Possess leadership and supervisory skills

Experience: Preferably with 3 years of relevant work experience in a pharmaceutical / veterinary laboratory doing related product study and development of processes and up to its commercial processing He must know the validation processes from start to end

Work location

CARMONA, CAVITE

Remarks

No additional remarks

About the company

In 1999, Blaine established its toll/manufacturing arm, REFAMED RESEARCH LABORATORY CORPORATION, to give customers all the benefits of customized quality products. RRLC is a Certified ISO 9001:2008, GMP Certified, globally competitive Philippine based company that incessantly invest on res...

Industry

MANUFACTURING

Employment size

200 and over (Large)

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