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Apotex
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Lead Exec, Quality

Lead Exec, Quality

Apotex

3 - 5 years

17 - 18 Lacs

mumbai

Posted:3 days ago| Platform:

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Skills Required

product launch product quality manager quality assurance compliance focus pharma manager quality control gmp licensing recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for managing the Quality Product Compliance files for Canada and the U.S. Additionally, acts as the primary Quality contact for products which Apotex acts as a contract manufacturer.

Acts as liaison between Apotex s manufacturing sites and customer affiliates.

Job Responsibilities

Maintain Quality Product Compliance files for all 3rd party contract manufactured product in which Apotex is the Marketing Authorization holder or acts as a distributor for the Canadian market; this includes formally requesting annually with our vendors their current approved master documentation, stability summary reports. Follows up with vendors to ensure all documents are received.

Develops and maintains Quality Product Compliance files for the US market place based on current GMP Regulations.
Perform assigned Post implementation tasks from TrackWise.

Initiate the Change Controls in TrackWise, where no RA assessment required.

Tracking of confirmatory testing & batch record review (Initial launch batches and annual batches).

Request and obtain vendor APRs as per the schedule on time.

Maintain and track unique identifier documentation and expiry and ensure up to date.
Acts as the liaison between external customers and our internal functional groups in order to provide customer quality requests in a timely manner.
Interacts with internal functional groups including stability, quality assurance, quality control, regulatory affairs and quality compliance for obtaining the necessary documentation and handling customer requests.

Tracks open requests from customers to ensure timely responses. Escalate to senior management any significant delays.

Assist External Manufacturing Quality with follow up for new product launch, change control or deviations.

Ensure that documents are in full compliance with GMP, and regulatory standards.
Performs all work in accordance with all established regulatory and compliance and safety requirements.

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
- Bachelor of Science Degree/Community College Diploma (or equivalent) in a related discipline.
Knowledge, Skills and Abilities
- Effective in communicating (speak, read and write) in English
- Excellent organizational skills and the ability to manage time effectively
- Strong interpersonal skills and very customer focussed
- Must be detail-oriented, accurate and reliable
- Must be able to work independently with minimal supervision
- Ability to follow instructions according to written procedures
- Ability to manage multiple priorities in a fast-paced and changing environment
- Knowledge of GMP and regulatory requirements

Experience
- Three to five years of experience in a pharmaceutical environment
- Familiarity with MS Word, Excel and Access is an asset

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