Senior Manager, QA(Compliance & Risk Mgt)

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com.

Job Summary

Serves as a Senior Manager role within Compliance & Risk Management at Apotex Research Private Limited, and as a senior professional practitioner within the following areas of expertise:

• Handling of Product Recalls, Returned drug Products and Field Alert Reports,
• Escalations of critical events to Site and Global management and
• Quality Performance Indicators (QPIs)
• Inspection Management
• Corrective and Preventive Actions (CAPAs)
• Annual Product Quality Report (APQRs)
• Quality Compliance & Risk Management activities.
• Apotex Quality Compliance Alerts
• Internal Audit management
• Handling of Market Complaints.
• Artwork Management.
• Supplier Quality Management
• Cross Contamination
• Handling of Failure and deviation investigation
• Handling of Training management
• Change control management

Job Responsibilities

• Responsible and accountable for competently managing subordinates and to provide all required training, equipment, tools and follow procedures in accordance with applicable regulatory & other pertinent requirements.
• Interacts with other Operations and R&D departments to discuss and resolve CAPA process issues and update procedures as required.
• Responsible for application of Quality Systems and enhancement of the systems. Establish metrics to measure the effectiveness of the system.
• Act as a Super User role for QMS – Track Wise Change control.
• Act as Lead Auditor in execution and completion of Internal Audits / Supplier Audits.
• Ensures the Compliance of all the Post – marketing activities such as Recalls, returned products, FARs, APQR, Quality Compliance alerts, market complaints.
• Responsible for handling of Quality management systems such as Training, Change control management, Investigation handling, artwork management, Internal audit management, CAPA, supplier quality management.
• Assists the Head – Quality and Compliance in achieving departmental goals and objectives
• Provides technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance. Ensures implementation of appropriate business processes and controls including SOPs, in order to maintain effective quality standards.
• Provides support for pre-approval inspections and audits by Regulatory Authorities as well as third parties as required.
• Provide information/insight on regulatory requirements and stay abreast of changes in regulatory environment/ trends.
• Establish quality standards to ensure overall compliance.
• Responsible for internal audits and supplier qualification program.
• Communicates corporate vision and goals to direct reports in an effective and efficient manner.
• Set priorities and goals for Compliance and assists direct reports in priority setting.
• Plan staffing and budget requirements for the Compliance and Risk Management department.
• Recruit, train, develop and manage effectively the ongoing performance of the direct reports, which includes, but is not limited to:
• Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually,
• Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties,
• Providing coaching, feedback and recognition.
• Develops direct reports by providing challenging and stretching tasks and assignments, building a solid foundation of skill sets. Coaches supervisors to manage training, development and performance of staff.
• To coordinate and organize the Management Review meetings
• Lead user for SAP support system to members of working area
• Certified trainer for QMS Track Wise (Investigation, Excursions, CAPA and Audits Observations).
• Certified trainer for GMP Modules at ARPL
• Responsible to perform the GMP rounds (ad hoc/verifications) within ARPL to ensure/sustain the state of compliance.
• Project Lead for Remediation Action Plan (RAP) at ARPL
• Co-ordination with Apotex Inc., global field market response team for incident response & market action, product recall & market action and regulatory reporting
• Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment).
• Works as a member of a team to achieve all outcomes.

Job Requirements

• Education
  • Minimum of Master Degree holder in Chemistry or Pharmacy.
• Knowledge, Skills and Abilities
  • Leadership skills
  • Possess sound knowledge in implementation and maintaining the Compliance of Quality management System.
  • Hands-on experience in Trackwise application, SAP, Livelink etc.,
  • Possess technical skills in investigation tools and techniques and implementation of CAPAs.
  • Possess experience in performing Supplier Audits
  • Sound knowledge in Preparation and Review of APQR’s
  • Maintains good Interpersonal skills and communication skills
• Experience
  • 15 years of experience in GMP Regulated industry.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
 
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.