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Aceto Pharma
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Quality Service Specialist , EU

Quality Service Specialist , EU

Aceto Pharma

2 - 4 years

3 - 7 Lacs

bengaluru

Posted:1 day ago| Platform:

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Skills Required

supply chain iso analytical quality systems agile regulatory compliance support services logistics management gmp service quality

Work Mode

Work from Office

Job Type

Full Time

Job Description

In furtherance of that goal, Actylis is seeking new members of the team. This expansion, coupled with a comprehensive benefits package, and opportunities for challenge and growth, make Actylis the ideal place to work and thrive. We hope you'll consider joining us!

Position summary:

The Quality Service Specialist primarily supports commercial and customer

quality document requests.

Key Responsibilities:

Develop Goals and Motivations for Excellence in Quality Support Services:

Place the interests of the Commercial Team and the Customer first; our success depends on their success.

Be highly responsive and timely to the Commercial Team and Customer Key Accounts.

Meet deadlines; communicate status and delays to the Team and customers proactively.

Pursue an unrelenting quest for quality; use speed and simplicity to achieve goals.

Communicate pleasantly and effectively.

Demonstrate professional etiquette and courtesy when interfacing with customers.

Conduct oneself with the highest level of integrity and business ethics.

Commit to teamwork; seek out and use the ideas and skills of all colleagues.

Reach for the highest standards of performance; show a passion for winning.

Commercial Team Support Function:

Curate any and all Commercial Team and direct Customer Requests.

Process information received from Commercial Team personnel via SFDC or the shared email inbox.

Manage and prioritize information to ensure timely delivery as per the established SLAs.

Organize and maintain documentation received in the Quality sharepoint and/or MasterControl and conduct follow-up, as applicable.

Liaise with internal and external stakeholders to resolve customer requests.

Complies with and adheres to all regulatory compliance areas, policies and procedures.

Identifies and implements best practices in Quality Services.

Keep all document logs and SFDC task queue up-to-date.

Review weekly tasks and responsibilities with direct supervisor.

Coordinate the review and signature of CDA/NDAs and QAAs.

Coordinate the completion of customer questionnaires, declarations and statements.

Update Actylis Statements, Declaration and documents including but not limited to: TSE/BSE, Elemental Impurities, Residual Solvents, GMO, Allergens, Melamine, Prop 65, etc

Respond to Product Information Requests including but not limited to: Specifications, Typical COAs, Certificate of Origin, Test Methods, Shelf-Life Letter, Manufacturer and Supply Chain Information, Packaging Specification/Information, Storage Conditions Statement, Stability Statement, Stability Data, Example Label, etc

Manage product Information packages based on ICH and/or IPEC guidelines.

Act as liaison in organizing the timing and set-up of customer audits.

Qualifications Experience:

Bachelor s degree in science (Chemistry)or related field.

Minimum of 2-4 years of experience in Pharma industry.

Functional/Technical Competencies Skillsets

Quality Systems knowledge (ISO and GMP).

Proficiency in quality management systems and auditing techniques.

Strong analytical and problem-solving skills.

Excellent communication and interpersonal skills.

Ability to read, understand and apply complex instructions/regulations.

Ability to work independently and as part of a team.

Attention to detail.

Self-starter.

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