POSITION SUMMARY: Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Quality & Compliance Specialist (QA) to join our Quality Assurance (QA) team. This Quality Compliance Specialist opening will have an emphasis on supporting the manufacturing operations of our 24x7 facility. The Specialist will directly support the implementation, execution, and maintenance of Quality Systems related to manufacturing to ensure the PPS-Riverview site complies with regulatory requirements as propagated by the United States Food and Drug Administration (USFDA) and other international regulatory authorities. Principle assignments related to compliance may include material release, review and implementation of new and revised documentation to support PPS-Riverview Quality Systems and operations to meet Good Manufacturing Process (GMP) requirements. The scope of this position will support both clinical and commercial manufacturing, as well as process development, in the Riverview facility. This is a shift-based position; the selected candidate must be willing to work weekends, and holidays as needed on a rotating schedule.
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:
· Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
· Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
· Identify and protect the original technical information as part of the company property.
KEY RESPONSIBILITIES.
· Review of batch production records (including analytical test packages, cleaning records, etc.): The incumbent’s primary responsibility will be to ensure that batches meet GMP requirements and are manufactured according to approved Standard Operating Procedures (SOP), and appropriate resolution to batches pending approval due to GMP errors and related corrective action investigations. Review in-process batch records, finished product batch records and intermediate analytical records. Release intermediate products, based upon conformance with specifications and completion of associated documents.
· Operations Support: Actively walk the production areas to promote and ensure current Good Manufacturing Practices are being adhered to. In real time address any corrections or deviations with production staff explaining the impact and how to avoid the error moving forward. Review all batch related data generated by the Production team in real time during the shift, including but not limited to executed batch records, temperature recordings, cleaning records, In-process checks, equipment status tags and logbooks for accuracy, completeness and compliance to data integrity.
· Administrative Duties: Support QA administrative duties such as; issuing master production records and appropriate labeling to manufacturing, ensuring that the current version is issued. File completed batch production records, testing records, and cleaning records. Support maintenance of document tracking systems.
· Audits: Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during an audit. Conduct internal audits and housekeeping inspections and walkthrough’s of site Quality Systems and related operations to ensure compliance with written procedures. Audits quality system and records, creating documentation as needed. Follow-up as appropriate to ensure corrective action is implemented. During an audit of ASH, participate in the audit to explain ASH’s quality
systems and operations. The incumbent is expected to represent ASH’s systems thoroughly and positively, being receptive to the auditor’s comments. Participate in the development of a formal response to audit report as appropriate.
· Reports/Document Management: This may include support to Annual Product Reviews, Non-Conforming Material Reports, and Investigation Reports. Participate in preparation or review of associated documentation, such as Analytical Methods Validation Reports, Cleaning Validation Reports, and Process Validation Reports.
· Quality Systems Support: Ensure compliance with internal approved procedures of all generated data. Participate in the implementation of continuous initiatives as they relate to production and quality activities. Provide data and information pertaining to operations or systems for internal or external clients as requested. Identify trends from batches that are associated with deviations/corrections and present corrective actions in order to reduce the number of deviations/corrections. Assist in effective implementation of data integrity procedures and overall data integrity compliance in Production. Perform other related assignments and projects as required.
· Metrics: Perform routine and adhoc Quality Systems Metric Reporting and analysis for the local site data. Prepare metrics and perform trend analysis in support of management review.
· Risk Management: Participate in the Risk Management program, including updating risk analysis, participating in applicable teams and maintaining Risk Management documents.
EDUCATION/EXPERIENCE.
· Bachelor’s degree in the physical or biological sciences or engineering with 1 or more years’ experience in
pharmaceutical operations/quality or another GMP environment.
· Associate’s degree with 2 or more years’ experience in pharmaceutical operations, regulated life sciences, or
quality assurance.
· Individuals without a degree but having at least 3-5 years’ experience in pharmaceutical operations, regulated life sciences, quality assurance, or an equivalent combination of Quality and technical education will also be considered.
· Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
· Strong computer skills with MS Office (e.g. Word, Visio and Excel), Relational Databases, Reporting and statistical tools.
· Proficient in TrackWise, SAP and Master Control or experience working with document management and ERP systems.
JOB COMPETENCIES.
· Excellent organizational and planning skills.
· Strong written, verbal, and interpersonal communication skills.
· Strong attention to detail orientation.
· Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
· Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.
· Experience interacting with FDA or other regulatory agencies
· Knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, SPC, etc.)
· Must complete tasks independently and notify supervisor of decisions outside of established processes.
TIME REQUIRED IN JOB TO REACH EFFECTIVE PERFORMANCE.
· Induction period: 3 months
· Time to reach performance effectiveness: 6 months
JOB CONDITIONS.
The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Physical Demands:
o Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
o Long periods of standing and walking can be expected in this position.
o This position may require long periods of sitting, typing, computer entry or looking at a computer.
· Work Environment:
o Piramal Pharma Solutions (PPS) is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
o Potential limited exposure to hazardous chemicals.
o Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
Work Location: In person
