QA Manager or Assistant Manager


Job ID 18-00325

Industry Computer/IT

Job Type Contract

Location East Windsor, NJ

Description

JOB SUMMARY

The QA Assistant Manager is responsible for implementation, management and support of applicable elements of Pharmaceutical Quality System.
 

REPORTING RELATIONSHIPS

4 employees reporting to this position. 
 

DUTIES & ESSENTIAL JOB FUNCTIONS

Specific Responsibilities include:
- Develops, evaluates and revises processes/procedures to ensure compliance with GMP/GLP/GDP regulations and guidelines.
- Manages various QMS processes including Document & Records Control, Internal Audits, Supplier Management, Quality Agreements, Training, and CAPA.
- Compile data for documentation of test procedures and prepare reports.
- Create, advise on and support the establishment and continual improvement of Standard Operating Procedures and Work Instructions.
- Develop validation master plans based on FDA/EMA guidance for all processes and methods related to our lead product and follow on products (GMP).
- Provides QA review and approval of production batch records and testing results, specification changes, product non-conformances, deviations and protocols/reports (e.g., validations, qualifications, capability, stability)
- Executes Gap Analysis and/or Risk Assessments
- Develop the change control system including Corrective and Preventive Actions.
- Develop and implement supplier qualification system and oversight program to fully qualify all suppliers, CMO and CRO.
- Provide technical response and expertise during audits, inspections and due diligence.
- Review and validation of all equipment and utilities.
- Assure preclinical studies are performed in accordance with international Good Laboratory Practice (GLP) standards and Company policies & procedures.
- Conduct or monitor audits to review protocol, data, reports and in-lab audits as per GLP requirements.
- Supervise and guide inspectors.
- Assure the reliability and consistency of production by checking processes and final output.
- Primary facility/plant FDA contact
- Review current standards and policies.
- Final QA Approval for Investigations, CAPA's, Change Control, Field Alert Preparation
- Keep records of quality reports, statistical reviews and relevant documentation.
- Ensure all legal standards are met.
- Communicate with external quality assurance officers during on-site inspections.
- Maintain up-to-date knowledge of cGMP regulatory issues, industry and affiliated publications, standards and guidance.

 

DUTIES & ESSENTIAL JOB FUNCTIONS
30    Daily    Approve batch records, change controls, deviations CAPA
20    Daily    Conduct investigations, review and approve investigations.
20    Daily    Review and approve Quality control documents.
10    Daily    Approve and release batches for commercial distribution
10    Daily    Attend management meetings 
10    Daily    Review and approve SOP's.

 

OTHER FUNCTIONS AND RESPONSIBILITIES
Perform other duties as assigned.
 



Qualifications

QUALIFICATIONS / REQUIREMENTS

  • Bachelor's Degree in Pharmaceutical/Life/Technical Sciences
  • Master or excellent knowledge of international regulations (e.g., FDA, GMP, ICH).
  • Fluency in both written and spoken English.
  • At least 5 years of experience in Quality Assurance within a pharmaceutical field, including practice in conducting and/or monitoring audits.
  • Significant Experience working with in Pharmaceutical manufacturing and validations
  • Must be detailed oriented, possess excellent time management skills, be well organized, a self-starter and display a professional demeanor with a high focus on quality, compliance, and responsibilities.
  • Leadership skills with the ability to develop employees and maintain an atmosphere of positive     growth and achievement; a self-starter with minimum oversight required to accomplish goals.
  • Must possess excellent communication and technical writing skills, strong interpersonal skills, and ability to work with others in a positive and collaborative manner; able to communicate with sense of urgency to internal and external customers.
  • Must have experience hosting FDA and related government inspections
  • Must be able to work as a team member, maintaining day-to-day activities while being responsive to changing priorities.
  • Demonstrated experience with implementation/improvement of quality systems to ensure efficiency and effectiveness.
  • Experience with the development and implementation of current validation systems in the     pharmaceutical industry.
  • Experience in developing and generating quality system metrics/trending. -Extensive knowledge of Root Cause Analysis / Risk Management / Good Manufacturing Practices / Quality System Regulations and ISO Standards is required.
  • Proficient with PC based office computers and standard Microsoft Office applications.
  • Willingness to travel to investigator, vendor, or regulatory agency meetings and audits, as needed.
  • Good team skills and ability to work in an interdisciplinary and international environment.
  • Possess a high degree of personal responsibility.

PREFERRED

  • Master's Degree in Pharmaceutical or related life sciences.
  • Good Communication Skills
  • Master or excellent knowledge of international regulations (e.g., FDA, GMP, ICH).

 

ANY REQUIRED LICENSES/CERTIFICATIONS/MEMBERSHIPS, ETC. 

CQA but not mandatory.

 

LEADERSHIP SKILLS / ABILITIES:

Encourage team members to take ownership of their projects, keep people motivated and continuously coach employees to meet the highest quality standards. 

 

MANAGEMENT SKILLS / ABILITIES:

Planning, Organizing, Coordinating, Directing and Oversight