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Engaged Employer

Apotex Research

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4.1

based on 786 Reviews

Video summary

23 Apotex Research Jobs

Lead Executive, MS&T - CPV

APOTEX PHARMACHEM INDIA PRIVATE LIMITED

4.1

based on 786 Reviews

8-10 years

₹ 8.65 - 13.61L/yr (AmbitionBox estimate)

Mumbai

1 vacancy

Lead Executive, MS&T - CPV

Apotex Research

posted 5mon ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy SAP CO Recruitment Data Enrichment Time Management HR Policies

+ 1 more

Job Description

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, RD, 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 .

Responsible for preparation and coordination of Process Validation-Stage 3 (CPV) studies, in accordance with FDA, HPFBI, EC, and ICH s guidelines and applicable Apotex policies and processes.

Job Responsibilities

Creates protocol/reports and other documentation related to CPV Stage 3B, in PACE and other systems.
Collects data from SAP and LIMS and other quality system to compile reports, performs statistical analysis and evaluations, as required and ensures that CPV reports follows Apotex procedures and policies.
Creates and reviews projects in PACE and ensures completion of all actions in PACE (e.g. validation history, batch planning), as applicable.
Monitors and assesses Stage 3B trending of products as required.
Coordinates and executes all related activities with cross-functional teams for timely escalation and closure of reports.
Supports CPV management in achieving departmental goals.
Works in a safe manner collaborating as a team member to achieve all outcomes.
Demonstrates Behaviours that exhibit our organizational Values Collaboration, Courage, Perseverance, and Passion.
Ensures personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, policies and procedures, Safety and Environment policies, and HR policies.
Works with the Supervisor, assists in coordinating the training of new employees.

All other relevant duties as assigned

Job Requirements

Education
- Degree, Diploma or Certification in Chemistry, Pharmaceutical Technology, Pharmacy or related science
Knowledge, Skills and Abilities
- Proven organizational, problem solving, and project and time management skills demonstrated by previous work experience, in order to manage multiple priorities in a fast-paced environment.
- High level of familiarity with Excel, Word, PowerPoint and statistical tools required.
- Excellent English oral and written communication skills.
- Knowledge of validation concepts and regulatory guidances (e.g. PV guidance, ICH 8, 9, 10, 12) is an asset
- Ability to be flexible and multi-task in a rapidly changing environment.
Experience
- Minimum 8-10year of experience in the pharmaceutical 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.

Employment Type: Full Time, Permanent

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