QA Specialist

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.

Responsibilities

• Function as primary FLQA and Quality Management System (QMS) subject matter expert to assigned area(s) of responsibility within Bulk Manufacturing, QC laboratories, Fill Finish Manufacturing, Facilities, and Warehouse operations.
• Perform quality oversight and approval of Deviations, CAPAs, and Change Controls in collaboration with Record Owners. Ensure investigations, cause identification, CAPA development, and accurate change controls within Bulk, QC, Fill Finish, FacOps, and Warehouse departments.
• Track closure of assigned QMS records.
• Participate in suite team meetings, provide FLQA support for projects and initiatives.
• Conduct on-the-floor walkthroughs and coaching to instill a quality mindset, compliance knowledge, and a strong quality culture among manufacturing staff.
• Bring adherence to and continuous improvement of quality systems within Bulk, QC, Fill Finish, FacOps, and Warehouse departments.
• Support development, revision, and implementation of SOPs, protocols, and other GMP documents.
• Help deliver Deviation, CAPA, and Change Control Annual Product Quality Review (APQR) sub-reports.
• Lead continuous improvement projects, offer quality support to site capital projects and global quality system improvements.
• Ensure inspection readiness through routine quality walkthroughs, monitoring adherence, and direct involvement in Site Self Inspections.
• Be a QA SME for internal and external audits.
• Proficiently use computerized systems including TrackWise, Veeva QMS and QDocs, GLIMS, SAP, CMMS.
• Provide support to greater FLQA organization, including quality oversight of Bulk Manufacturing/QC Laboratories and QA reviews of batch records and GMP records at the site.
• Acquire and maintain knowledge of current local and international regulatory requirements/trends, ensuring advice and technical support on quality/compliance matters are provided to the site.

Requirements

• Bachelor's degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) preferred or equivalent experience in biotech or pharmaceutical industry
• 3 years' GMP experience in the pharmaceutical/biotech industry
• Previous experience directly working in the industry or having direct responsibilities approving GMP deviations, CAPAs, and change controls.
• Previous experience in root cause analysis and risk management, including working experience of root cause analysis tools such as Fishbone/5Why
• Previous experience in quality role in an FDA regulated manufacturing or laboratory setting or an understanding of the quality requirements for the pharmaceutical industry.
• Experience with the production processes used in pharmaceutical parenteral drug product manufacturing.