About the Job
Follow technical and administrative work such as checking, receiving and registration of samples, sorting of samples to the test areas, tests carried out are according to the method specified, results are precise and accurate, and tests are completed as per sample priority and due date, accurate data entry, generating the reports, and timely delivery of results and reports, without compromising on the quality, accuracy and procedures.
Be responsible for routine/non-routine QC Functional Laboratory analysis of finished products, process validation, Investigation, NC/CAPA. The candidate must demonstrate experience working in a cGMP laboratory and possess basic knowledge of industry regulations related to pharmaceutical and medical device manufacturing. Assist senior staff in method validation and method development.
About the Role
Essential Duties
- Check, receive and register of samples, sorting samples to the test areas.
- Prepare testing samples, solutions, standards and reagents to support testing.
- Perform functional analysis under the direction of senior staff with compliance to the procedures and standards, with timely delivery as per sample priority or due date, without compromising the quality and accuracy.
- Able to perform other testing upon completion training of test methods and Verification of Effectiveness (VOE) of QC Microbiology and QC Chemistry Team.
- Have analytical skills in the maintenance, operation and interpretation of the results obtained from analytical instruments.
- Perform routine maintenance activities in the laboratory and participate in the qualification and periodic calibration of equipment.
- Perform training for entry level staff and peer-to-peer training.
- Identify and troubleshoot problems with instrumentation and analytical preparations.
- Assist senior staff for the execution of method validations, qualifications, and transfers.
- Assist with Lab OOS/NC/CAPA Investigations in his/ her area.
- Able to perform review of all worksheets and logbooks.
- Conduct supporting duties such as wash and dry apparatus and vials and reject and discard samples.
- Support in inventory of spares, gases, chemicals, consumables etc. to ensure no incidence of zero stock level.
- Record any verifications, maintenance and calibration or repair works in the respective equipment logbook.
- Practice 5S and conduct self-audit as per sectional audit checklist.
- Maintain filing records as per record management retention schedule by filing the worksheets, shredding expired records to ensure that there are no expired records maintained.
- Follow Good Manufacturing Practices (cGMP) as well as all safety regulations and company procedures.
- Adhere to all safety regulations and practices conforming to EHS regulations.
- Support with Internal/External Audit such as FDA, ISO, etc.
Qualifications
- Minimum College/University Degree (with basic background in science)
Required Skills
- Computer literate and Effective communication skills verbal, written and excellent listening skills.
- Self-motivated and proactive - Fully committed to improving the lab performance - Improvements / modification to workflow and quality improvement.
- Team player
- Able to perform the job independently.
- Possess good planning, coordinating, managing and time management skills.
- Able to engage with cross-functional teams and external stakeholders.
- -Or- An equivalent competency level acquired through a variation of these qualifications may be considered.
Preferred Skills
- General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 25 kgs.
- Requirement that personnel assigned to inspection positions must not be color blind, ensuring they can accurately perform color-based visual inspection activities.
- The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Pay range and compensation package
Any non-essential functions to the position and expectations such as occasional requirement to work outside normal work hours and/or travel.
Equal Opportunity Statement
We are committed to diversity and inclusivity.
