5-10 years of experience in Quality Assurance within the pharmaceutical industry.
Bachelor's degree in Science, preferably Chemistry, Microbiology, or Biology.
Proven experience in a regulated industry, particularly with FDA guidelines.
Strong written and verbal communication skills for effective interpersonal engagement.
Demonstrated ability to work independently and manage fluctuating workloads.
Responsibilities
Serve as the primary QA contact for customers and provide excellent customer service.
Review and approve key quality documents including deviations and validation reports.
Coordinate timely reviews and approvals of quality compliance issues with customers and internal teams.
Develop and manage Technical Quality Agreements to align quality systems with customer needs.
Generate quality metrics and reports to monitor the status of quality systems and client relationships.
Promote compliance culture at all organizational levels and ensure adherence to GMP and safety standards.
Assist in audits and inspections, including internal audits and those by regulatory bodies.
Benefits
Opportunities for professional development and training.
Collaboration with cross-functional teams to enhance customer relationships.
Participation in continuous improvement initiatives targeting customer satisfaction.
Potential involvement in strategic meetings with high-profile clients.
Engagement in a dynamic and fast-paced work environment.
Full Job Description
PRIMARY PURPOSE:
Provide customer service and serve as primary QA point of contact for customers.
Review and approve quality documents for customers such as Deviations, Master Batch Records, Change Controls, Validation Protocols and Reports, FG specifications and Test Methods.
Coordinate required functions across the site and with customers to ensure timely review and approval of deviations, change controls, audits CAPAS, corrections and effectiveness checks.
Develop Technical Quality Agreements and collaborate with customers to align customer and FS quality systems.
Develop and nurture customer partnership to ensure alignment and consensus.
Participate and coordinate meetings with customers as part of QA oversight for customer products.
Generate quality metrics, trackers, and reports for management and customers to characterize the health of the client relationship and state of quality systems.
Promote Compliance within the site at all levels and cross functional Teams.
Participate in the Internal Audit Program by performing site audits as required by QA Management.
Provide support during customer audits and Health Authorities inspections.
Support EHS audits (regulatory and customers) to scribe- file documents as required.
Conduct Investigations/CAPAs for quality events, ISO event, calibration events and safety quality related events as required by management.
Promote GMP and safety throughout the facility by training and coaching personnel to quality, regulatory and safety as tasked.
Accurately reviews and records data.
Promote continuous improvement and customer satisfaction.
Participate in other activities as assigned by the Director of QMS.
QUALIFICATIONS:
Experience working in Quality Assurance, QMS, Validation and Compliance.
Experience in a regulated industry (e.g., Food and Drug Administration).
Bachelor's Degree in Science (Chemistry, Microbiology or Biology preferred) required
A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.
CRITICAL SKILLS AND ABILITIES:
Working knowledge of FDA regulations for drugs and/or medical devices.
Skill in written and oral communications and in establishing effective interpersonal relationships.
Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and produce reports.
Ability to make quality decisions and act accordingly.
Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.
Ability to perform effectively under conditions of fluctuating workload.
Ability to handle and resolve recurring problems.
Communicate with others clearly and concisely.
Ability to work in a fast-paced environment - sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.
Strong initiative, technical commitment and contribution to company and departmental goals
