Role Objective:
A key objective of this profile is to ensure effective implementation of Production QMS requirements, SOP compliance, GMP practices, production documentation, and shop floor process control. The role is responsible for supporting production activities with strong focus on quality compliance, audit readiness, deviation/CAPA handling, change control, and continual improvement.
Desired Candidate Profile:
The candidate should have strong knowledge and practical experience in Production QMS and GMP-regulated manufacturing operations. The candidate should be capable of handling production documentation, SOP compliance, deviation, CAPA, change control, training compliance, and audit preparation. The candidate should be able to coordinate with QA, QC & Engineering departments to ensure smooth and compliant production operations
Role & Responsibilities:
- Ensure all production activities are performed as per approved SOPs, BMRs, formats, and QMS requirements.
- Review and ensure timely completion of production documents, logbooks, BMRs, and related records.
- Monitor GMP compliance and area discipline.
- Coordinate with QA for deviation, CAPA, change control, incident, risk assessment, and investigation activities.
- Support SOP preparation, revision, implementation, and training compliance.
- Ensure production team follows approved procedures and records all activities properly.
- Support internal audits, customer audits, and regulatory audit readiness.
- Track production quality issues, rejection trends, process gaps, and support corrective actions.
- Ensure proper handling of non-conforming products, hold batches, rework, and quality-related production issues.
- Support continual improvement activities to reduce rejection, documentation errors, and process deviations.
- Ensure operators are trained and qualified before performing assigned activities.
- Maintain compliance with safety, quality, productivity, and documentation requirements.
Functional Skills Required:
- Strong knowledge of Production QMS and GMP requirements.
- Knowledge of SOP, BMR, logbook, format, and production documentation control.
- Practical understanding of deviation, CAPA, change control, risk assessment, incident handling, and investigation.
- Knowledge of audit preparation and audit compliance.
- Understanding of production planning, shop floor execution, and manpower handling.
- Ability to identify process gaps and implement corrective/preventive actions.
- Knowledge of training compliance and operator qualification requirements.
- Good coordination skills with QA, QC, Engineering, Store, and Planning.
- Basic computer knowledge, MS Excel, documentation, and report preparation.
- Knowledge of regulated manufacturing environment and quality system expectations.
Behavioral Skills Required:
- Strong ownership and accountability.
- Good communication and coordination skills.
- Detail-oriented approach toward documentation and compliance.
- Problem-solving and decision-making ability.
- Positive attitude toward quality and continual improvement.
- Discipline, punctuality, and professional work approach.
- Ability to escalate issues at the right time.
- Strong follow-up and execution capability.
Team Size to be Handled:
Individual contributor role, reporting to the Manager Production.
Important Links:
Website:https://biotechhealthcare.com/
LinkedIn:https://www.linkedin.com/company/biotechhealthcare/
Instagram:Biotech Vision Care
Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.
