Position: Quality Assurance Officer/Sr. Officer

Number of Vacancies: 1
Department: Quality Assurance (QA)
Experience: 3 to 5 years of experience
Reporting To: QA Manager
Location: Ambernath (Manufacturing Site)
Expected Date of Joining: At the earliest
Employment Type: Full Time

Desired Educational Qualification: M.Sc. in Organic/Analytical Chemistry

Preferred Candidate Profile: M.Sc. Chemistry candidate with 3 - 5 years of relevant experience in the QA department of a Pharmaceutical/API, Specialty Chemicals, Fine Chemicals, Food Additives, Flavour & Fragrance or allied manufacturing industry.

Candidates should possess strong documentation skills and hands-on exposure to GMP, ISO systems, audits and QA documentation.
Experience in ISO management systems, GMP documentation, and plant QA systems will be preferred.
Preference will be given to candidates residing in or willing to relocate to Ambernath, Badlapur, Kalyan, Dombivli, Thane or nearby locations.

Purpose of the position
To ensure effective implementation and maintenance of the Quality Assurance Management System at the manufacturing site by ensuring compliance with GMP, ISO standards, QHSE requirements, customer requirements, and applicable regulatory standards.

The incumbent will support documentation control, quality systems, audits, sustainability initiatives, and continual improvement activities.

Key Responsibilities:

Perform routine QA activities in the manufacturing plant.

Prepare, review and control Standard Operating Procedures (SOPs), formats, specifications and quality-related documents.

Ensure adherence to GMP, Quality, Safety & Internal standards of Kalpsutra Chemicals





Maintain manufacturing plant related documentation, records, logs and compliance.
Participate in internal audits and regulatory inspections as required.
SOP preparation, prepare documents/records pertaining to ISO standards and Sustainability (EcoVadis & SEDEX) initiatives.

Coordinate with Admin, Production, Maintenance and QC departments to ensure compliance with quality, health, safety, environment (QHSE) & regulatory requirements.

Handle documents related to Root Cause Analysis, CAPA, Change Control & other QA Systems.

Review of QC data, including Gas Chromatography (GC), as per approved procedures.

Participate in internal audits, customer audits and regulatory inspections.

Ensure compliance with applicable Quality, Health, Safety & Workplace (QHSE) requirements.

Record and maintain manufacturing plant related records, analytical test data & reports.

Support & assist in implementation and monitoring of quality systems and procedures.

Desired Skills & Competencies:
Strong knowledge of Quality Assurance principles and Quality Management Systems, GMP, ISO standards and documentation practices.
Strong analytical and problem-solving skills.
Detailed knowledge of Quality Assurance and Quality Control documentations.
Proficiency in Microsoft Office (Excel, Word, PowerPoint and Outlook) is mandatory.
Good verbal & written communication and interpersonal skills and attention to detail.
Familiarity with Lab instruments such as GC and HPLC will be an added advantage.
Knowledge of Root Cause Analysis, CAPA, Change Control and document control systems.
Ability to work independently and in cross-functional teams
Positive attitude, willingness to learn and ability to work in a manufacturing environment.

📌 Quality Assurance Officer (Mumbai)
🏢 Kaar Quest
📍 Mumbai