Actylis is a global solutions provider with over 75 years of experience, specializing in streamlining the management of critical ingredients and raw materials for our business partners.

We offer both sourcing and manufacturing solutions tailored to meet diverse and evolving needs, ensuring a reliable, agile, and secure supply network. Our commitment to customization allows us to create flexible solutions, whether it's a unique specification, custom packaging, or tailored logistics strategies.

With deep expertise in quality and regulatory compliance, sourcing and logistics management, analytical services, and R&D support, we reduce complexities and mitigate risks, empowering our partners to focus on growing their business.

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

This role define the complete handling and monitoring of QA department QMS activities, which includes management of complete quality system starts from document and data control, further include Change management, complaint management, deviation management, customer and regulatory audit handling and compliance writeups. The persons in the QA QMS section will also ensure audit readiness customer compliance and regulatory compliance. Will take the lead in completing the internal audits and manage the management review meetings. This role is will have extended responsibility in product release, registration and new product development and launches related to Quality responsibility.

Responsibilities will include:

Preparation, compilation, and approval of APQR of all products wherever applicable.

Equipment/Instrument /Utility Validation and documentation management.
Review and management of Batch Manufacturing records master document for PR-01, PR-02 and PR-03 production department.
Management of Change controls i.e. insurance, review, compilation, and life cycle management of change controls of whole site per change management procedure.
Management of Market complaint for Pharma excipient and LC products from start of complaint acknowledgement, receipt, investigation, handling of complaint sample till the closure of the complaint.
SAP item master creation, BOM updates and other critical transactions related to Pharma excipient products.
Quality Matrix Monthly/Quarterly/Half yearly and Annual preparation and compilation.
Monthly trend preparation of complaint per the procedure.,
Management and procedural execution of Management review meeting.
Management of different technical service providers per the procedures,
Aqua product license management and life cycle handling.
Issuance, retrieval including life cycle management of all GMP documents but not limited to Master copy, control copy, log books and executionary records per site documentation and data control procedures and maintenance.
Management of documents in Master control software as a doc controller.
To perform indent of logbooks from the service provider against the request.

Required Experience & Knowledge

Education

B.Pharma/M.Pharma, Msc. Chemistry, Btech or Mtech with biotechnology or chemistry.

Experience

5-6 years of experience in Pharmaceutical, API or excipient regulated industries.

Supervisory Responsibilities

No

Work Environment

Actylis is an Equal Opportunity Employer. Actylis US does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.

Executive - QA