Senior QA Manager

You will lead and manage the QA team to ensure compliance with cGMP, regulatory standards, and company SOPs. Your role will involve overseeing quality systems, including deviation management, change control, CAPA, OOS, and OOT investigations. It will be crucial for you to ensure quality assurance in sterile injectable manufacturing processes, emphasizing aseptic practices and cleanroom compliance.

In addition, you will be responsible for preparing, reviewing, and approving batch manufacturing/packaging records, protocols, and reports. You will also play a key role in conducting internal audits and supporting external audits such as regulatory inspections and customer audits. Monitoring vendor quality and ensuring raw materials/packaging compliance will be part of your routine tasks.

To excel in this role, you should have a Bachelor's or Master's degree in Pharmacy or a related field, along with 5-10 years of experience in the pharmaceutical industry, specifically with a minimum of 5 years in injectable manufacturing (sterile/aseptic). A strong understanding of cGMP and regulatory guidelines from bodies like USFDA, MHRA, EU, and WHO is essential. Hands-on experience in handling audits, documentation, and compliance processes will be beneficial, along with excellent leadership, problem-solving, and communication skills.

This is a full-time position that requires in-person work at the Amritsar location of Systacare. If you are passionate about ensuring quality in pharmaceutical manufacturing processes and are committed to upholding the highest standards of compliance, we encourage you to apply for this role and be a part of our dynamic team at Systacare.,