Executive, Mts Process Validation

4 weeks ago

Mumbai Maharashtra, India Apotex Research Private Limited Full time

**About Apotex Inc.**

**Job Summary**:
Responsible for processing and managing changes to Master Production documentation as recommended by the Manufacturing Technical Services team as part of the Product Life Cycle Management.

**Responsibilities**:

- Responsible for initiating change control packages in the change management system with detailed change(s) descriptions and the corresponding rationale(s).
- Collaborate with Scientific Leaders and Quality to perform a thorough and complete impact analysis for the change control package.
- Facilitate the compiling of supporting documentation (i.e. Mark-ups, reports).
- Ensure all related documents and data affected by a change request are captured.
- Ensure changes outlined in the change management system coincide with mark-ups and/or proposed change.
- Prepare Validation Manufacturing draft documents and corresponding SAP master recipes mark-ups as per the Manufacturing Technical Services (MTS) report to be included as supporting documentation in the change management system.
- Track and follow up the progress of change control requests to meet committed business timelines. Ensure that Change Control Requests are completed and closed-out within due date or request for due date extension if required.
- Initiate and co-ordinate F8 and F9 in SAP to facilitate validation activities and SLED extension
- Responsible and accountable for acting as a technical resource to internal/external customers and key stakeholders in troubleshooting and resolving challenges faced during technical documentation creation and/or revisions.
- Generate Demonstration Manufacturing and Submission Manufacturing masters as per Experimental Protocol to be used in the execution of production batch manufacture.
- Generate R&D Stability Packaging masters as a required to cover submission stability requirements. Act as a liaison between Formulation Development, R&D QA and the Manufacturing Technical Services teams to ensure MMaR and BPaR creation is accurate and delivered as per schedule.
- Ongoing maintenance of all tracking databases and folders related to the functions of the Manufacturing Technical Services group. Filing and recording of Manufacturing Technical Services master documents and executed batch records in designated Database and storage locations
- Collect and provide Regulatory Affairs with the necessary information as requested for the Regulatory submission package.
- Participates and contributes in cross - functional team activities and puts team goals ahead of individual goals. Provides constructive feedback, demonstrates coaching skills and candid with team members while maintaining professionalism and tact.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviors 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’s/ Master’s degree in Science / Pharmacy Minimum University Degree or College Diploma in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering or related science.
- **Knowledge, Skills and Abilities**:

- Demonstrated attention to detail, accuracy, and timelines.
- Ability to work in a high-paced environment as a team player and independently.
- Ability to complete and coordinate projects with strict deadlines.
- Excellent organization, troubleshooting, and word processing skills.
- Advanced knowledge of various computer software packages including Microsoft Office Suite - Word, Excel, PowerPoint,
- **Experience**
- Minimum 5-8 years relevant working experience in the pharmaceutical industry.
- SAP experience is an asset.

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.

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