CAREERS

Initiate the introduction of Formulation Development products by doing due diligence, gap assessment (Gap Analysis) and perform and review all risks associated with introduction of new products at Qcil

Carry out Formulation Development trials, feasibility batches & associated activities on introduced products until successful development of the product which can then be transferred to Technology Transfer team for full scale manufacturing

Co-ordinate with relevant sections for effective project planning, execution, project review to enable smooth operation of documentation and Formulation Development activities for new products

Prepare all the necessary documentation including Formulation Development protocols and reports, annex for Critical Process parameters to be demonstrated, Master Batch Records, SOPs, Equipment Qualification Documents, Equipment Equivalence Documents, Change Requests, etc

Develop and pack formulation batches as per the applicable SOPs and approve development process to ensure successful execution of Formulation Development

Manage the requisitions, inventory of spares, tooling, consumables related to Formulation Development through close collaboration with OEM, Engineering, and Supply Chain departments ensuring all-year round availability through stock/inventory management

Prepare, and review all QMS, Audits, investigations, Corrective Action and Preventative Action (CAPA), effectiveness, compliance, reviews in regulatory requirements in relation to operations within the Formulation Development section that enable timely support and response to all CFT requirements

Compile Analytical Development reports with the Formulation Development Pharmacist for submission to Regulatory Affairs Department

Work with Technology Transfer team in successful product execution

Any other job responsibility/ assignment given by Supervisor/ Manager deemed fit within your jurisdiction

Bachelor’s Degree in Pharmacy, Pharmaceutical Science or any other related field

Minimum of 2 years’ experience in a pharmaceutical manufacturing plant

Familiar with pharmaceutical regulations and guidelines, such as Good Manufacturing Practices (GMP) and International Council for Harmonization (ICH) guidelines

Certification in Quality Management or Quality Assurance is an added advantage

Good teamwork, interpersonal skills and adherence to Quality Management Systems

Self-starter, flexible and able to work well under pressure at work

Proficiency in Excel and its basic formulae, and in PowerPoint presentations

Familiar with the various analytical tools like the Pareto Chart, Waterfall, Pie Charts, Bar Charts and Line Charts

Be observant, creative and innovative in line with the business needs

Able to work Shifts program as per business needs

Carry out comparative dissolution studies for test products and reference comparator products to assure pharmaceutical equivalence

Carry out cleaning validation for new products that are developed at Formulation Development

Carry out analytical method validations and verifications and compile reports for the same to the Formulation Development to assure the consistency of the developed analytical method

Perform Analytical Method Transfer during transfer of the products from Formulation Development to Manufacturing

Carry out accelerated and long-term stability studies as well as compile reports of the same

Conduct impurity profiling of drug substances including the identification and quantification of impurities

Assist the Formulation Development Quality Chemical Officers in developing analytical methods, such as spectroscopy-based methods, chromatographic methods or dissolution methods amongst others

Assist the Formulation Development Officers in conducting experiments, analysing results and preparing reports for various pharmaceutical formulations developed

Execute and report experimental work related to biopharmaceutical characterization in support of drug product development

Participate in the evaluation of new analytical techniques in the area of pre-formulation sciences, automated workflows and biorelevant testing

Create and review specifications in the SAP system

Handle ERP System/ SAP for specification generations and Trackwise system for deviation and complaints

Prepare SOPs, FMECAs, protocols, and any other documents assigned by the line manager from time to time

Any other job responsibility/ assignment given by Supervisor/ Manager deemed fit within your jurisdiction

Bachelor’s Degree in Chemistry, Chemical Engineering, Industrial Chemistry, or Science Technology (Chemistry), or any other science related field

Minimum of 3 years’ experience in Quality Control in a manufacturing plant or standard recognized laboratory

Familiar with pharmaceutical regulations and guidelines, such as Good Manufacturing Practices (GMP) and International Council for Harmonization (ICH) guidelines

Certification in Quality Management or Quality Assurance is an added advantage

Good teamwork, interpersonal skills and adherence to Quality Management Systems

Self-starter, flexible and able to work well under pressure at work

Proficiency in Excel and its basic formulae, and in PowerPoint presentations

Familiar with the various analytical tools like the Pareto Chart, Waterfall, Pie Charts, Bar Charts and Line Charts

Be observant, creative and innovative in line with the business needs

Able to work Shifts program as per business needs