QA Compliance Associate

  • Torrent Pharma Inc.
  • Levittown, PA, USA
  • Jul 20, 2020
Full time Quality Control

Job Description

The Compliance Associate oversees and conducts internal and external audits. Routine job responsibilities include the evaluation of all departments and associated documentation for adherence to Torrent procedures and regulatory requirements as well as providing support during regulatory or customer audits of Torrent Pharma. The Compliance Associate/Senior Associate will report to the Head of QMS and Compliance and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of QMS and Compliance or the Site Head of Quality.      

Essential Duties and Responsibilities:

  • Prepare the annual schedule for internal audits, conduct and document internal audits, track and provide follow-up on corrective actions
  • Work closely with personnel in all departments ensuring procedures are being followed and documentation requirements are being performed as required to ensure product quality and compliance to company procedures and regulatory requirements
  • Support external, regulatory or certification audits and interact with FDA as needed
  • Coordinate interdepartmentally and draft responses to external and regulatory audits
  • Identify and oversee the implementation of the appropriate corrective and preventive actions (CAPA) to prevent deviation occurrence/reoccurrence
  • Manage CAPAs to ensure timely closure of actions resulting from various types of audits
  • Track and provide follow-up to corrective actions and commitments pertaining to external and regulatory audits
  • Manage Effectiveness Checks to ensure they are completed by the required due date and perform closure of Effectiveness Checks
  • Provide metrics as requested to track/trend audit observations
  • Performs analysis of key quality indicators and analyzes data to identify areas for improvement in the quality system
  • Generates and facilitates changes to SOPs, policies, training materials, and other documents to assure compliance and continuous improvement.
  • Assists in the QA review of investigations, root cause analysis, and Corrective and Preventive Action (CAPA) plans related to process / product deviations, material testing, and Out-of-Specification events
  • Notifies management of quality/compliance trends.
  • Maintains knowledge of current regulatory requirements pertaining to pharmaceutical products
  • Maintains effective communication and partnership with all departments across the organization
  • Maintains a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations.
  • Ensure all work is performed and documented in accordance with GMP requirements and existing company policies and procedures
  • Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues.
  • Proactive, good organizational and time management skills
  • Follow and enforce GMP and GDP and applicable Standard Operating Procedures. Report any concerns immediately to Management.
  • Assist with training of new and current employees on Quality and Compliance related subject matter and participate in department or company projects/initiatives as requested
  • Interact with any and all other departments to resolve any issues regarding internal/external audits
  • Other duties may be assigned by the Head of QMS and Compliance, or Site Head of Quality

 

Safety Requirements:

  • Ensure adherence to all personal protective equipment:
  • Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources

 

Competencies/Skills:  

  • Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
  • Strong organizational skills and the ability to multitask        
  • Demonstrated ability in working independently and as part of a team
  • Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
  • Excellent communication (oral and written) and interpersonal skills
  • Must be able to communicate technical, scientific, and regulatory information, both written and verbally
  • Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance

                               

Education and/or Experience:                                                   

  • Bachelor’s degree; Degree in Chemistry, Biology or related science is preferred.
  • Minimum of three (3) years of experience working in a GMP environment.
  • Minimum of three (3) years of experience in a Quality role in a pharmaceutical manufacturing environment.
  • Lean, Six Sigma and cGMP experience preferred.

 

Language Skills:                                                             

  • ability to read and comprehend instructions in the English language through verbal and written method.
  • ability to write or speak in the English language information effectively in one-on-one and in group of employees within the organization.

 

Mathematical Skills:                                                      

  • ability to interpret data utilizing intermediate math operations; statistical analysis

 

Reasoning Ability:                                                         

  • ability to apply common sense understanding to carry out multi-step instructions
  • deal with standardized situations with occasional variables

 

Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.
  • frequently lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

 

Work Environment: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Noise level in the work environment is usually moderate, but may be loud at times.