Sr. Executive /Assistant Manager -QA QMS

MJ Biopharm; Pune District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

MJ Biopharm in Pune is seeking a QA/Regulatory professional responsible for Change Control, CAPA, deviation handling, regulatory compliance, and document control to ensure QMS adherence in a biotech environment.

The role emphasizes training, SOP reviews, and cross-functional collaboration with engineering, production, and RA teams to maintain quality standards and regulatory readiness in Maharashtra.

Qualifications

• Knowledge of cGMP and regulatory requirements related to QA, validation and calibration.
• Training on QMS functions and basic SOPs.
• Experience with validation, qualification and calibration SOPs across departments.
• Awareness of processes, especially engineering operation, utilities and equipment.
• Good communication skills with cross-functional teams.
• Awareness of software and PLC related to biotech equipment operations.

Skills

cGMP Knowledge

Regulatory Awareness

QMS Training

Validation & Calibration

Engineering Process Awareness

Cross-functional Communication

Job description

Authorized, Responsible and accountable for,

1. Change Control, Deviation and CAPA:

• Handling of Change Control, Incident / Deviation and CAPA.
• Following and tracking of Change Control, Incident /Deviation and CAPA.
• Involved in the investigation activity whenever required.
• Responsible for overall QA compliance activity.

1. QRM & MRM:

• Assigning the risk assessment number as per requirement.
• Responsible for reviewing the action plan submitted by all departments and suggesting changes wherever required.
• Responsible for preparing the minutes of meeting the Quality Review Meeting and Management Review Meeting.
• Preparation and review of the risk assessment.
• Preparation of PPT and scheduling Quality Review Meeting and Management Review Meeting.

1. Training and Development:

• Tracking and maintaining the employees training.
• Annual cGMP training for new Employee.
• SOP training evaluation of all departments.
• Maintain Specimen signature records for all employees.
• Imparting the training to cross functional teams like Engineering, production, and other departments on the relevant topics.

1. Document control:

• To prepare controlled copy, uncontrolled copy and other copy as per the requirement and issue to the concern Department / Personnel.
• Monitor the maintenance of the soft copies, hard copies and obsolete copies of all QMS documents.

1. Regulatory compliance:

• Single point of Contact for coordinating with regulatory affairs team and cross functional team to facilitate regulatory compliance requirements.
• Scheduling and tracking regular meetings with RA team to understand the regulatory requirements.

1. Apex documents / SOPs/STPs/Specs:

• Preparation and review of SOPs, logbooks for QA department.
• Review of other departments SOPs for correctness.
• Review of STPs and specifications.

1. Documentation Room:

• Segregation of documents as per displayed room and update the list of documents on a regular basis.
• Management and handling of the documents in the documents room.
• Labeling of the documents/Files/other documents as per requirement.
• Co-ordination with RA for document sharing.
• Perform task and activities assigned by HOD whenever required.

Skills & traits required:

• 1. Knowledge of various cGMP and Regulatory requirements related to Validation, Qualification and Calibration.
• 2. Training on QMS functions / Basic SOPs.
• 3. Training on Validation, Qualification and Calibration SOPs (QA and other departments).
• 4. Awareness on Process especially related to Engineering operation, utilities and Equipment.
• 5. Good Communication skills with cross functional team.
• 6. Awareness on Software, PLC related to Biotech Equipment’s operations