Quality Assurance Specialist

The Position

The Role

Ensures on-floor GMP compliance during manufacturing and packaging and supports batch release activities through in-process oversight, batch record review, deviation escalation, and verification of compliance prior to batch disposition.

Your Opportunities

Job Responsibilities:

• Responsible for document management such as issuance, storage, retention and destruction of documents and records as per defined procedure.
• To ensure good documentation by all concerned personnel and all the documents are as per current GMP requirements and in-house SOPs.
• Preparation of standard operating procedure and provide training on SOPs.
• Responsible for maintaining audit documents such as regulatory and customer audit report and response.
• To ensure that batch production operations are carried out in accordance with cGMP and procedure mentioned in respective batch record.
• Monitoring of manufacturing/packing activities on routine basis.
• Ensure compliance in Warehouse, Manufacturing and Packing.
• To review the batch records including associated data, logbooks etc and to track monthly batch release activities.
• To review master documents.
• Ensure that cGMP requirements are been followed and monitored in the critical process areas.
• To ensure good documentation by all the concerned and all the documents are as per current GMP requirements and in-house SOPs.
• To participate and ensure satisfactory technology transfer, process validation, cleaning validation and hold time studies.
• To implement CAPA for internal & external audits.
• Responsible to participate in investigations.
• To participate in audits and to provide relevant information, when required.
• To prepare Product quality review.
• To Participate in qualification activities.
• Ensure safe work practices, and usage of recommended PPE during activity.
• Ensure compliance to EHS policy and its requirements.
• Responsible for management of document room including labelling and arrangement of files, storage, issuance, and retrieval on approved request.
• Issuance of batch manufacturing and packaging records to production department as per request.
• Any other responsibilities assigned by department head.

Who You Are

• Working knowledge of Microsoft excel, word, power point etc.
• Relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs
• Experience with health authority inspections and third-party audits
• Understanding of pharmaceutical manufacturing and laboratory work (including familiarity with various analytical techniques) a strong asset
  • Decision-making skills.
  • Excellent communications skills in English (verbal, written, listening, email writing)
• Technical writing skills
• Problem solving skills
• Understanding of manufacturing processes and/or quality systems elements
  • Data analysis skills are required
• Able to work in shifts
• Good communication skills.
• Ability to work as part of a team.

We Are Acino

At Acino, we push the boundaries to deliver high-quality pharmaceutical products that improve patients’ lives. Driven by our collective purpose to provide access to medicines to those in need, our strength lies in our unique expertise and presence in emerging and high-growth markets. We are proud to be challenging the status quo in the pharmaceutical industry, always looking ahead to the future with an open mind.

Join Acino, a dynamic and rapidly growing environment where your contributions can make a real difference.

Acino is an Equal Opportunity Employer.

How To Apply

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!

 

Only direct applications will be considered. Please apply via our HR system here.