Marksans Pharma Ltd hiring for Multiple Positions

Join Our Team at Marksans Pharma Ltd. – Verna, Goa

Job Title: Assistant Manager / Executive / Officer – QMS Documentation (Production)

Role Overview:

This role ensures that the documentation system in the production department complies with applicable regulatory standards (like WHO, GMP, EU, USFDA) and supports quality assurance through meticulous document control. The candidate acts as a link between production operations and the QA/QC departments for documentation and compliance matters.

Detailed Responsibilities:
1. Documentation Management:
* Draft, revise, and control Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Batch Packaging Records (BPRs).
* Maintain master copies and ensure timely issuance of controlled copies of documents.
* Archive completed documents as per the document retention policy.
* Ensure real-time data entry and updates on ERP/document management systems (if applicable).

2. Quality Compliance:
* Support implementation of QMS elements like Deviation Management, CAPA (Corrective and Preventive Actions), Change Control, and Risk Management in production.
* Assist in the investigation and documentation of non-conformances, deviations, and complaints.
* Ensure traceability and accuracy in all production records and logs.

3. Audit Support:
* Prepare and present relevant documentation during internal, customer, and regulatory audits.
* Participate in audit response and follow-up actions in coordination with the QA team.

4. GMP & GDP Monitoring:
* Regularly audit documentation practices on the production floor to ensure compliance with

5. Good Documentation Practices (GDP).
* Provide guidance and training to production staff on documentation-related SOPs and regulatory updates.

**Preferred Skills:**
* Understanding of pharmaceutical production processes (granulation, compression, coating, filling, etc.).
* Familiarity with quality standards: ISO 9001, ICH Q10, WHO GMP, USFDA CFR Part 210/211.
* Knowledge of electronic documentation systems (e.g., MasterControl, TrackWise, SAP-QMS).
* Strong organizational and time-management skills.
* Analytical thinking with problem-solving ability.

**Career Path:**

With experience, the individual may move into:

QMS Coordinator / Manager, QA Executive (Compliance/Documentation), Regulatory Affairs, Production Manager (GMP Compliance focus)

– Experience – 4 to 12 Years

– Qualification – B. Pharmacy / M. Pharmacy

Interested candidates may send their updated resume to ajit.sambare@marksanspharma.com.

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