QA Associate
PSC Biotech
- Makati City, Metro Manila
- Permanent
- Full-time
- Identify and implement process improvements in our ACE QMS system and workflows and/or procedural events.
- Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Support and execute software validation protocols. Assist in the development of quality systems and metrology systems as needed.
- Review, author, and develop required documentation including standard operating procedures, test methods, raw material specification, protocols, and related control documents. Ensure instructions are clear and are consistent with quality objectives.
- Perform independent technical review of documentation during and post-execution of cGMP activities. Document review includes but is not limited to batch records, calibration records, QC data, enviornmental data, and maintenance records.
- Write and execute deviations, CAPA, and conduct effectiveness checks.
- Follow safety initiates and assist upper management with the compliance of SOPs and specifications
- Ensure all specifications are met and that applicable requirements are completed and acceptable.
- Analyze and report data/findings to appropriate departments.
- Collaborate with cross-functional teams/departments to investigate and review any potential risks or issues. Implement effective mitigation strategies.
- Assist in preparing for inspections by regulatory committiees or customers.
- Particpate in audits remotely.
- Additional responsbilities as required.
- Must be able to support 8am - 5pm US EST time zone.
- Must be able to travel for 1 month duration, twice a year.
- 3-5 years of direct experience in a Quality Assurance role within the pharmaceutical manufacturing/sterile manufacturing environment.
- Strong knowledge of pharmaceutical operations.
- Aseptic experience is preferred.
- Strong knowledge and understanding of QA principles, concepts, industry practices, and standards.
- Proficient in writing, reviewing, and investigating quality events.
- Experienced leading internal projects or initiatives. Ability to serve as a resource for team memebers.
- Experienced with electronic systems and QMS systems, such as Veeva, SAP, LIMS, TrackWise, etc.
- Strong knowledge of EU and US markets, standards, and regulations.
- Proven success in reviewing and supporting quality documentation such as batch records, calibration/maintenance records, quality data, and so on.
- Strong technical writing skills with proven success in writing deviations, CAPA, etc.
- Detail-oriented and able to demonstrate a high standard of integrity.
- Excellent time managment and organizational skills.
- Strong independent judgement and decision making capabilities.
- Excellent interpersonal and communication skills (both verbal and written).
- Proven success working collaboratively on a global team.