QA Manager Indenta chemicals india pvt ltd
Indenta chemicals india pvt ltd
Office Location
Full Time
Experience: 5 - 5 years required
Pay:
Salary Information not included
Type: Full Time
Location: Maharashtra
Skills: change control, Documentation, Stability studies, Calibration, Regulatory Guidelines, Trend Analysis, Continuous improvement, Quality Control Management, ISO Documentation, manpower handling, Communication, FDA GMP audits, Quality Management Systems QMS Setup, Standard Operating Procedures SOPs, OOT, OOS Management, Regulatory Standards, Deviations, CAPA, Qualifications, Validations, Quality Risk Management, Sampling, Testing
About Indenta Chemicals India Pvt Ltd
Job Description
As a QA Assistant Manager with 5-7 years of experience in the pharmaceutical industry, you will be responsible for running the department independently. Your role will require strong skills in inter and intra-departmental communication, a desire to learn, and the ability to adapt and adopt to people and systems effectively. This position is based in Mumbai. Your key responsibilities will include: - Skilled handling of FDA-GMP audits to ensure compliance with regulatory standards. - Experience in establishing robust Quality Management Systems (QMS) to ensure compliance with GLP and cGMP standards. - Expertise in creating, reviewing, and maintaining Standard Operating Procedures (SOPs). - Managing and implementing change control processes effectively. - Proficient in preparing and maintaining Site Master Files, Master Validation Plans, and Batch Manufacturing Records (BMRs). - Conducting stability studies, managing stability programs, and handling Out of Trend (OOT) and Out of Specification (OOS) results. - Establishing and maintaining standards according to current regulatory guidelines and Pharmacopeia revisions. - Evaluating deviations, managing change controls, and implementing corrective and preventive actions (CAPA). - Proficient in equipment qualification, process validation, cleaning validation, and method validation. - Overseeing the calibration of equipment and adhering to ICHQ7A guidelines and other regulatory standards. - Conducting trend analysis, providing feedback for continuous improvement, and implementing Quality Risk Management strategies. - Working towards continuous improvement of quality systems and efficiently managing Quality Control departments. - Handling ISO documentation procedures, including quality manuals, work instructions, checklists, and audits. - Managing sampling and testing of excipients, Essential Oils, and Aroma chemicals. - Strong skills in effective manpower handling and communication in English, both oral and written. This is a full-time position with benefits including Provident Fund. The work schedule is day shift, and the work location is in person.,