Deputy Manager - External R&D

Apotex Inc.; Bengaluru; On-site; INR 1,400,000 - 2,200,000; Full time

Job summary

Apotex Inc. in Bengaluru seeks a Project Leader, External R&D QA Third Party to manage disposition activities for non-commercial batches produced by third parties.

You will review master documentation, method validation, and change controls while coordinating with external partners to ensure GMP compliance. The role requires a B.Sc in Chemistry or related science, strong GMP knowledge, and 6+ years in pharma.

Qualifications

• Thorough knowledge of GMPs required.
• Knowledge of new product development process and of pharmaceuticals/biopharmaceuticals is an asset.
• Excellent verbal and written communication and organizational skills.
• Ability to work independently and in a team.

Responsibilities

• Act as the primary R&D QA contact for all product quality issues for non-commercial batches manufactured by third party partners.
• Review and approve master documentation, laboratory testing/protocols/reports and related change controls.
• Conduct impact analysis of proposed CAPAs with Apotex subject matter experts.
• Review and approve method validation and technology transfer protocols and reports.
• Establish and maintain a system to trend investigations and quality issues for third party partners.
• Ensure complete and accurate batch documents and closure of investigations prior to release.
• Provide support during regulatory inspections and assist in resolution of quality concerns.

Skills

GMP knowledge

Communication skills

Organizational skills

Independent work

Teamwork

Education

B.Sc in Chemistry, Biochemistry or a related science

Job description

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com .

Job Summary

The Project Leader, External R&D QA Third Party is responsible for the disposition activities of non-commercial finished products (for small molecules and biopharmaceuticals) manufactured by third party partners for Apotex. The incumbent acts as a technical resource and reviews master documentation, analytical method validation, change control, manufacturing/packaging documentation, test results and investigations for R&D clinical, submission or stability batches. This person also provides support for coordinating activities for establishing R&D Quality Agreements where required with third party partners.

Job Responsibilities

• Act as the primary R&D QA contact for all product quality issues for non-commercial batches manufactured by third party partners.
• Review and approve master documentation, laboratory testing/protocols/reports, stability protocols and associated change controls from third party partners for non-commercial batches.
• Conduct impact analysis of the proposed corrective & preventative actions by engaging Apotex subject matter experts, as required.
• Review and approve method validation and technology transfer protocols and reports.
• Establish and maintain a system to trend investigations and create visibility of quality related issues for third party partners.
• Ensure that all manufacturing, packaging and analytical documents pertaining to the batch are complete, accurate and reviewed and all investigations/deviations have been closed prior to release.
• Performs final disposition/release of batches for clinical studies or rejects batches where required.
• Provide support to external partners to stay abreast of regulatory inspections at their sites and assists in resolution of quality concerns arising from those inspections.
• Assist with auditing of external partners to ensure GMP compliance.
• Act as the R&D point of contact for the transition from R&D Quality to Commercial Quality.
• Work in a cross functional team to ensure the delivery of quality submissions.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • B.Sc in Chemistry, Biochemistry or a related science.
• Knowledge, Skills and Abilities
  • Thorough knowledge of GMPs required.
  • Knowledge of new product development process and of pharmaceuticals and biopharmaceuticals is an asset.
  • Excellent verbal and written communication and organizational skills.
  • Ability to effectively work both independently and in a team environment.
• Experience
  • Minimum of 6 years of experience in the pharmaceutical industry.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer 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.