Officer - Production (QMS)

Finecure Pharmaceuticals Ltd.; Sanand; On-site; INR 600,000 - 900,000; Full time

Job summary

Finecure Pharmaceuticals Ltd. in Gujarat seeks a QMS Documentation Specialist to develop, implement, and update shop floor documentation, including SOPs, WIs, control plans, and BPRs.

You will ensure GMP/CGMP compliance, finalize SOPs and records, train teams on QMS practices, and collaborate with manufacturing, quality assurance, and regulatory groups to resolve quality issues.

Qualifications

• Experience in creating and updating SOPs, BMRs, and BPRs.
• Familiar with GMP/CGMP standards on the shop floor.
• Ability to train teams on QMS principles.

Responsibilities

• Develop, implement, and update QMS docs on the shop floor (SOPs, WIs, Control Plans, BPRs).
• Handle GMP & CGMP compliant processes and documents.
• Prepare and finalize SOPs, BMRs, and BPRs.
• Develop and maintain SOPs for sampling, testing, and product release.
• Provide QMS training to team members.
• Collaborate with cross-functional teams to resolve quality and regulatory issues.

Skills

QMS knowledge

SOP writing

GMP/CGMP

Training

Cross-functional collaboration

Tools

Documentation tools

Job description

Roles and Responsibilities

• Develop, implement, and update QMS documentation on the shop floor, including Standard Operating Procedures (SOPs), Work Instructions (WIs), Control Plans, and Batch Production Records.
• Handle process & documents with GMP & CGMP.
• Prepare and finalize new SOPS/ BMR/ BPR
• Develop and maintain SOPs for quality control measures such as sampling, testing, and release of products.
• Provide training on QMS principles and best practices to team members.
• Collaborate with cross-functional teams to resolve issues related to product quality and regulatory requirements.