Deputy Manager - External Research & Development

APOTEX; Bengaluru; On-site; INR 1,200,000 - 2,400,000; Full time

Benefits offered by this job

Accommodation for applicants with disa

Job summary

APOTEX seeks a Deputy Manager - External Research & Development to lead QA activities for non‑commercial batches manufactured by third party partners in India. The role covers review of master docs, validation and transfer protocols, and ensuring GMP compliance across R&D and clinical batches.

You will coordinate investigations, support regulatory audits, and drive quality improvements in collaboration with cross-functional teams, while upholding company values and safety standards.

Qualifications

• GMP knowledge is required.
• Excellent verbal and written communication skills.
• Able to work independently and in a cross-functional team.
• Minimum 6 years of pharmaceutical industry experience.

Responsibilities

• Act as primary R&D QA contact for non-commercial batches with third party partners.
• Review master documentation, testing protocols, reports, and change controls.
• Conduct impact analysis of corrective actions with subject matter experts.
• Approve method validation and tech transfer protocols and reports.
• Maintain trend systems for quality investigations with external partners.
• Ensure all batch documents are complete and deviations closed prior to release.
• Dispositions for clinical studies or rejects batches as required.
• Support external partners during regulatory inspections and GMP compliance audits.

Skills

GMP knowledge

Analytical thinking

Communication skills

Team collaboration

Education

B.Sc in Chemistry, Biochemistry

Job description

Deputy Manager - External Research & Development

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.

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.