Assistant Manager - External Quality

Apotex; Mumbai; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Apotex in Mumbai, India, seeks an experienced QA professional to support the quality systems required to ensure regulatory and GMP compliance for Apotex suppliers. You will work with External Quality Managers to negotiate Supplier Quality Agreements, review GMP documents, and monitor compliance across multiple manufacturing sites.

Strong English communication and teamwork are essential. This role requires 8+ years in pharmaceutical QA/QC, familiarity with international regulations, and

Qualifications

• Minimum B.Sc. in Biology, Microbiology, Chemistry or Pharmacy.
• Strong knowledge of GMPs and QA/QC systems in pharma.
• Excellent written and spoken English; strong interpersonal skills.

Responsibilities

• Negotiate customer Quality Agreements with suppliers; ensure GMP compliance.
• Ensure Quality Agreements are current for vendors across sites.
• Liaise with Apotex Suppliers to negotiate Supplier Quality Agreements.
• Monitor and track status of Quality Agreements.
• Review GMP Quality Documents for Product Compliance Files.

Skills

Quality systems

GMP knowledge

QA/QC in pharma

English communication

Interpersonal skills

Education

B.Sc. in Biology/Microbiology/Chemistry/Pharmacy

Job description

Job Summary

Reporting to the General Manager, QA 3rd Party Ops, India, this role is responsible for supporting the Quality Systems required to ensure that Apotex meets its regulatory and GMP compliance obligations for Apotex Suppliers.

Support Managers with compliance activities for Third Party Organizations and Customer Operations.

Responsible for executing GMP activities related to the corporate governance of Suppliers to global Apotex Manufacturing Sites.

Job Responsibilities

• Negotiates with external suppliers on the provisions of the customer Quality Agreements. Makes decisions in consultation with the Manager, External Quality on the respective quality responsibilities to ensure both parties are compliant to GMP and meet Apotex internal standards.
• Responsible for ensuring that Quality Agreements are in place and current for vendors supplying to multiple Apotex Manufacturing Sites.
• Liaise directly with Apotex Suppliers in negotiating Supplier Quality Agreements and escalate to management when roadblocks occur.
• Monitor and track status of Quality Agreements.
• Provides support to External Quality Managers, in reviewing GMP Quality Documents that form part of Product Compliance Files.
• Reviews third party manufacturer s Stability protocols and Summary Reports.
• Reviews and approves third party manufacturer s Change Controls.
• Provides support to Customer Operations Manager, in processing customer requests for products manufactured by Apotex for Third Parties.
• Works as a member of a team to achieve all outcomes.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Corporate Values: Collaboration, Courage, Perseverance, and Passion.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Minimum B.Sc. in Biology, Microbiology, Chemistry, Pharmacy or a related science
• Knowledge, Skills and Abilities
  • Must be familiar with overall pharmaceutical manufacturing and quality systems/process.
  • Good knowledge of global GMPs and QA/QC systems associated with the manufacture of human drug products.
  • Excellent written and verbal English communication skills.
  • Excellent interpersonal skills and ability to relate well to internal and external customers.
• Experience
  • Minimum 8 years experience in the pharmaceutical industry with relevant QA/QC/Mfg experience, preferably with multiple dosage forms.
  • Experience with international regulations (e.g. Health Canda, US FDA, EU) is an asset.
  • Must be detail oriented, accurate and reliable. Demonstrate personal leadership and accountability. Excellent organization skills and analytical thinking.