Job Description :

- Ensure change control system

- Ensuring the Maintenance of Documents related to CCF, CAPA, Deviation, OOS, OOTs, Product technical complaints and Product Recall / Return.

- Preparation and Review of Standard Operating Procedures.

- Active participation in system design, effective Implementation and monitoring of quality systems.

- Preparation and updating of Site Master File, Quality Manual and trending of quality systems.

- Ensure Product technical complaints are fully investigated and reviewed.

- Advocating continual improvement of operations and the quality system.

- Internal communication on quality issues at all levels in the organization.

- Ensuring the review and issuance of the documents.

- To coordinate the corporate communications.

- Ensuring of Data Control Systems, Issuance of Numbering and ensuring accuracy of all documentation activities.

- Preparation of presentations related to Quality systems and as on requirement.

- Ensure all time readiness for Audits.

- Management of Global Quality Documents.

- Other Responsibilities delegated by department head as per the Requirement. Execution of Regulatory inspections.

- Ensuring the response to the regulatory audit observations are provided with in stipulated time.

- Adhere to HSE instructions and procedures.

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Employment Type: Permanent Job, Full Time

Keyskills

Change Control Quality Systems Standard Operating Procedures System Design Internal Communication documentation QA

Desired Candidate Profile :

- Working experience as a Documentation professional.

- Excellent communication and leadership skills.

- Thorough knowledge of applicable procedures, specifications, standards and regulations (USFDA, MHRA, EUGMP etc.).

- Excellent knowledge on Document system handlings.

- Strong interpersonal/ communication/ influencing/ negotiation skills.

- Person should have minimum 2 years experience in documentation department as Manager.

Desired: Advanced computer skills (MS-Office)

Education: Master of Science (M.Sc.) Microbiology/ chemistry/ biotechnology is required.

M Pharmacy/ B Pharmacy also can be considered.

Interested candidates forward their updated resume and talk to Ms. Sravanthi on 9989488750.

Education-

UG: B.Pharma - Pharmacy, B.Sc - Chemistry, Microbiology

PG:M.Pharma - Pharmacy, MS/M.Sc(Science) - Biotechnology, Chemistry, Microbiology

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