Aculife Healthcare Private Ltd
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We Are Hiring For…Quality Management System (QMS)..!!
Job Title: Executive / Senior Executive
Department: Quality Assurance (QMS)
Experience: 3-8 years of relevant experience in a Quality Management System (QMS) or Quality Assurance (QA) role within an Injectable Pharmaceutical manufacturing facility.
Location: Sachana, Ahmedabad, Gujarat, India
Education: Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm), Biotechnology, Chemistry, or a related scientific discipline.
Job Summary:-
We are seeking a highly motivated and experienced Quality Management System (QMS) professional to join our dynamic Quality Assurance team in our Injectable Pharmaceutical manufacturing facility. The successful candidate will be responsible for ensuring the robust implementation, maintenance, and continuous improvement of our Quality Management System, in strict adherence to national and international regulatory guidelines (e.g., cGMP, USFDA, EMA, ICH, WHO, Schedule M). This role is critical in ensuring the safety, efficacy, and quality of our injectable products.
Key Responsibilities:-
1) QMS Implementation & Maintenance:-
Develop, implement, and maintain the company’s Quality Management System (QMS) for injectable products, ensuring compliance with current Good Manufacturing Practices (cGMP), and other applicable regulatory requirements (e.g., USFDA 21 CFR Parts 210 & 211, EU GMP, ICH Q10, PIC/S GMP).
Ensure all QMS documentation (e.g., Quality Manual, Quality Policy, SOPs, Work Instructions, Specifications, Batch Manufacturing Records, Batch Packing Records, Logbooks) are controlled, up-to-date, and readily accessible.
Support the implementation of an electronic Quality Management System (eQMS) if applicable.
2)Deviation, CAPA, and Change Control Management:
3)Documentation and Record Management:
4)Audits and Compliance:
5)Training & Quality Culture:
6)Product Lifecycle Management (APQR/PQR, OOS/OOT, Complaints):
7)Supplier Qualification & Management (if applicable to the role level):
8)Continuous Improvement:
9)Technical Knowledge:
Skills & Attributes:-
1)Excellent analytical and problem-solving skills with a strong attention to detail.
2)Strong written and verbal communication skills.
3)Ability to work independently and as part of a cross-functional team.
4)Proactive, self-motivated, and result-oriented.
5)Strong interpersonal skills and ability to interact effectively with all levels of 6)the organization and external stakeholders.
7)Ability to manage multiple priorities and work effectively under pressure.
8)Commitment to quality and continuous improvement.
Send Your CV :-
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