Assistant Manager

Responsible for QA activities like change control deviation OOS product noncompliance CAPA and product complaints 

Assuring GMP compliance through out the plant as per ISO and regulatory requirements

Responsible for document and data control of entire plant

Ensuring compliance for the deficiencies raised during GMP round

To involve in root cause analysis and initiate CAPA for the nonconformance raised during regulatory audit

Review and updation of department SOPs as and when required

Reviewing of VMP validation protocols and reports like process validation sterilization validation clean room validation and others

To identify and monitor department objectives for the completion

Interaction and coordination with other departments during validation activities to meet regulatory compliance

To review that the annual training is delivered to plant employees as per the schedule

Planing of Internal Quality audit and compiling the nonconformance report with supporting evidence

Interact and conduct meetings with other departments for Change control CDCR deviations nonconformance and other daytoday activities

Provide assurance that the product is analyzed and released as per the laid down specifications

Requirements

MPharm with specialization in QA from reputed college/ university with good academic record

Knowledge on cGMP and other regulatory guidelines

Reviewing skill for accuracy of documents and completeness of data

Awareness of QMS system and validations activities

Should have good communication and problem solving skills

Should be reliable and focused having an indepth thought process

Should be able to guide and manage a team of around employees

Benefits

Requirement for MLS Unit III for QA department

Experience 3 to 5 year post qualification in Internal audit (most preferably in medical device and pharmaceutical company) in manufacturing company. Qualification CA Having experience to work on - SAP ECC6.00 Good control over Excel, PPT and word General IT knowledge Behavioral Skills: 1. Able to communicate in written and verbal 2. Speedy acquiring business acumen 3. Analytical and critical thinking ability 4. Excellent logical reasoning ability 5. Excellent reporting skills 6. Excellent interpersonal skills