Quality & Regulatory – Asst manager

JOB DESCRIPTION

Doctor Pack is a global leader in the design, development, and manufacturing of Primary Packaging &innovative drug delivery System for the pharmaceutical, biotechnology, & generics industries. Some of the key products are eyedrops Packaging , Preservative Free Eye drops Packaging , Metered Dose Nasal Pumps ( Multi-dose) , Unit and Bi-Dose Nasal Pump , , inhalation devices like DPI and MDI ,  Auto-injectors , PFS ,  Insulin Pen , Tablet and Liquid Container closure system , Oral Syringe , Measuring Cup etc .

Job Description:

• You implement, obtain , maintain, and improve the Quality Management System such as 21 CFR 820 , ISO 13485 , ISO 15378 etc and EMS ISO 14001 , OSHA – ISO 45001.
• Updating & Approving in QT 9 QMS software and also SAP along with the team
• Prepare and maintain DHF , DMR , DHR , 510 K &documents for CE .
• Prepare and submit Type 3 DMF , DMR .
• Work on FDA site registration .
• Design Transfer ,  Control Plan Preparation and implementing in SAP .
• URS preparation for New purchase ,VMP, validating and new equipment qualification and conducting periodic validation as per VMP and SOP
•  BMR Generation /COA generation and approval .
• You report on QMS performance by providing relevant KPIs.
• You ensure NPI process and other applicable standards are properly used and applied within projects by auditing them internally.

• Deploys environment, health and safety policies to prevent accidents, safeguard the environment and better control consumption and waste.
• Deploys applicable quality policies and procedures and ensure compliance with applicable regulatory requirements.
• Train team on handling and documenting the Quality testing and measuring equipment .
• Participates in cross functional teams to help increase efficiency, solve problems, generate cost savings, improve quality and provide new product support through a continuous improvement approach.
• Preparing internal and External Audit and annual Training Plan and get it completed .
• MRM , CAPA , Change control , Deviation , Annual Product review , Customer feedback are to be completed timely .
• Carry periodic supplier audit , prepare and update the technical agreement with the supplier
• Handle customer and regulator audit and respond compliance within time .
• Responsibilities:
• Maintains data integrity and ensures compliance with company procedures and specifications, FDA, cGMP, and QSR regulations.
• Performs reviews of test data, which includes overall documentation practices.
• Ensures that laboratory and production equipment is qualified, calibrated and maintained and periodic calibration and requalification is done .
• Selects and orders new equipment and tools as necessary.
• Develops and validates methods for functional testing.
• Performs testing in a timely and appropriate manner to meet project schedules.
• Enforces the application of laboratory rules and procedures.

This description considers the main tasks but is not exhaustive.

Required Profile:

You hold any degree, or equivalent.

Minimum 3 year’s experience .

You have a background in pharmaceutical, industry and proven experience in leading quality Assurance and regulatory .

Hands on exposure on 21 CFR 820 , ISO 13485 , ISO 15378 , ISO 14001 , ISO 45001 , 21 CFR part 11,  CE , DMF and other QMS

Hands on Experience in DHF, DMR , DHR , Validation and Qualification .

Exposure to SAP , QMS software like QT 9 or other similar .

You are familiar with highly regulated and standardized environments.

You have strong experience in managing teams, plus managing direct customer contact.

You have strong leadership, convincing and communication abilities. You are granted with excellent interpersonal and organizational skills.

Doctor Pack is an equal opportunity employer and in accordance with our diversity policy we review all qualified applications including those of people with disabilities.