Contract Manufacturing Associate

Job Summary

Support Quality activities at Contract Manufacturing Organizations (CMO) by providing timely and effective quality oversight.

Accomplish quality objectives by planning and evaluating project activities. Support may include operations and validation.

Area of Responsibility

Review of manufacturing and packaging records

Review certificate of analysis and Certificate of compliance

Ensure the release packages are ready prior to batch disposition

Review of QMS records submitted by CMO and monitoring (e.g. change controls / deviations, quality agreements but not limited to)

Manage and oversee complaint, change control, and variation-filing modules for CMO activity.

Actively participate in day to day meetings

Participate in the qualification process and support assigned CMO aligned with the Sun Pharma Quality Management Systems and provide reports as required.

Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine CMO business review.

Implement and maintain Regional CMO data in the Global CMO database.

Ensure the Quality Assurance Agreements which are created and maintained according to Sun Pharma requirements, are regularly reviewed and followed.

Conduct review and approve batch release documentation.

Support significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.

appropriately and in a timely fashion.

Maintain annual auditing program, participate in technical visits and / or audits, manage action plans and follow up on agreed upon CAPAs.

Manage and oversee complaint module for Ohm Site. Work Conditions :

Office Environment

Lab Environment

Manufacturing Environment

Environmental related to manufacturing / production environments :

Noise : Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.

Fumes : Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.

Odors : Unpleasant smells.

JOB DESCRIPTION

Gases : Examples include carbon monoxide and ozone.

Dust : Airborne particles of any kind, such as textile dust, wood, and silica. Physical Requirements :

While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear.

The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.

Must be capable of bending and lifting, moving and / or carrying up to approximately 20 pounds.

Ability to navigate office, lab, and / or plant floor working environments, stands, ambulates, and reaches.

Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses / goggles, and safety shoes. Travel Estimate

Up to 10 % Education and Job Qualification

Minimum of a Bachelor’s degree in a scientific discipline; MS preferred.

Certified Quality Auditor (e.g. ASQ) certification preferred.

Expert skills related to investigations (e.g. Lean Six Sigma) Quality Agreements, and CMO management.

Ability to identify key priorities necessary for and be able to author / implement global policies and procedures.

Strong understanding of technical pharmaceutical processes as well as risk assessment and risk management fundamentals / tools.

Strong knowledge of cGMP, QA / QC and regulatory compliance (US, EU and other regulatory requirements).

Strong interpersonal and communication, both written and verbal, skills.

Good negotiation and influencing skills.

Operational knowledge of pharmaceutical processing and packaging operations.

Last updated : 2024-08-27