Executive - QA

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 defines the complete handling and monitoring of IPQA activities, which includes management of in-process controls from start of dispensing tll the completion of dispatch of the product from the facility. The IPQA team member should have proficient knowledge of batch manufacturing and packing operation per the regulatory, excipact and ISO requirements. This role is will have extended responsibility in product release, registration and new product development and launches related to Quality responsibility.

Responsibilities will include:

• To provide line clearance while executing operational activities for different departments like but not limited to – warehouse, liquid production, solid production, PR-03 area, packaging area, dispatch area etc.
• To review and approve Label content while packaging operation.
• To review all routine logbooks and records for all manufacturing and operational activities.
• To review the packaging record and batch manufacturing records for their completeness and correctness.
• To prepare and review process validation protocol and reports.
• To issue and maintain batch manufacturing record documents.
• To be responsible for batch release of finished products.
• To be part of process approver and verifier as quality assurance representative for dispatch of goods from facility.
• To document and manage the return goods and further operation activity.
• To monitor and ensure the calibration and preventive maintenance activity completion and proper tagging for all the equipment and instrument utilized in batch manufacturing, packing, and handling activity.
• To be part of SOP preparation and review for QA department and act as a reviewer for the SOP of cross functional department
• Preparation and review of process validation protocol and reports.
• Management of control sample for Pharma Finished products
• Management of customer samples and handling of customer sample request
• To be part of change control review process for all cross functional change control and part of investigation pertaining to and not limited to Deviation, Market complaint, nonconformance etc. where operations related investigation inputs and involvement needed
  
  

Required Experience & Knowledge

Education

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

Experience

2-5 years of experience in Pharmaceutical, API or excipient regulated industries.

Competencies & Skillsets

Functional / Technical

• Technical writing skills
• Document and data management skills
• Investigation tools and RCA tools knowledge
• Audit handling and auditing skills
• Technical knowledge of API/Excipient/Pharma manufacturing and packaging
  
  

Behavioral

• Good communication skills
• People Skills
• Cross functional collaboration
  
  

Supervisory Responsibilities

No

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..