29 Sop Compliance Jobs - Page 2

Roles & Responsibilities Author regulatory submission documents such as: Clinical Study Reports Investigator Brochures Responses to Questions Protocols and Protocol Amendments Informed Consent Forms Table of All Studies Clinical Overview Addenda eCTD Module 2 Clinical Summary Documents Briefing Documents Pediatric Investigation Plans Other regulatory documents as assigned Conduct formal review and approval of authored documents, adhering to SOPs Manage regulatory writing activities for product submissions under supervision, including new and supplemental drug applications/biologics license applications Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) Provide functional area input for Global Regulatory Plan and team goals Collaborate with contract and freelance writers as needed Participate in training and mentoring junior medical writers Engage in departmental and cross-departmental initiatives Generate document timelines with team input Stay updated on relevant professional information and technology Basic Qualifications Doctorate degree OR Master's degree with 46 years of directly related experience OR Bachelor's degree with 68 years of directly related experience OR Diploma with 1012 years of directly related experience Preferred Functional Skills Proficient with Microsoft Word and Office programs Strong knowledge of scientific/technical writing and editing Thorough understanding of clinical development processes for new compounds Ability to understand and follow complex SOPs, guidance documents, and work instructions Substantial knowledge of ICH and Good Clinical Practice (GCP) guidelines and requirements Soft Skills Excellent written and oral communication skills with strong attention to detail Demonstrated leadership abilities within a team environment involving negotiation, collaboration, and analytical judgment Effective time and project management skills Self-motivated with drive and perseverance to achieve results

Role & responsibilities 1.Internal Controls :- a.Understanding current processes and draft risk control matrix b.Identify loopholes in processes, devise action plan and revise the process c.Implementation of processes in line with Group and Gabriel SOPs d.Continuous checking of transactions to ensure controls are actually working e.Report findings, decide action plans and ensure deployment of the same in given timelines 2. Internal Audit Co-ordination: a.Handling of internal audit and co-ordinating with process owners for smooth handling 3.Secretarial Work:- a.Assist Company Secretary in Secretarial related work b.Ensuring compliance w.r.t. Companies Act, FEMA etc such as filing of forms, maintaining of statutory registers etc c.Drafting for Minutes of Meeting *Proficiency in MS Office *Strong organizational, analytical and interpersonal skills *Highly motivated individual with excellent problem-solving skills *Highly enterprising with excellent negotiation skills *Ability to prioritize work and perform under tight timelines *Able to work and deliver under minimal supervision/independently *Attention to details Interested candidate can send their cv on alka.p@peoplesource.in Thanks & Regards, Alka Pathak Tiwari Senior Recruitment Consultant (M) - +91 8720862919 Email: alka.p@peoplesource.in

Role & responsibilities To ensure timely documentation of housekeeping and to check the cleaning record on a daily basis. To ensure implementation of Standard Operating Procedures (SOPs) for administration and report to Department Head Manufacturing and QA if the deviation is observed. To check in-process control parameters of housekeeping through design document on a daily basis. To implement the GMP norms on a continuous basis. To ensure issuance of material as per the norms and SOP. To ensure good housekeeping of the entire plant, technical floor, ancillary services like canteen, utility building & campus. To ensure the proper upkeeping of housekeeping equipment, laundry equipment & office equipment inside the plant. To ensure pest control activities as per requirement. To ensure waste material handling area and disposal area are clean. To maintain the laundry facility inside the plant for washing of Clean Room Garments. To ensure the availability of general uniforms for staff & workers, factory shoes & locker facilities. To facilitate first aid services for any accident or general illness. For any major injury or accident, facilitate transportation to nearest medical facilities for medical treatments. To issue housekeeping materials for other departments. To maintain online documentation. To prepare daily and monthly report. To coordinate with campus administration for selling scrap and burning preprinted material. To ensure shoe cleaning of all staff and worker. To prepare requisition for housekeeping materials purchase. To suggest the change in SOPs if required. To ensure the availability of the workers for daily housekeeping activities. To ensure timely and quality cleaning for customer satisfaction. To monitor and control all SOPs and Current Good Manufacturing Practice (cGMP) Guidelines. Preferred candidate profile Lateral coordination Team working Policy compliance Task completion orientation Candidate from pharma company would be preferred. Interested candidate can share their CV at [HIDDEN TEXT]

Role & responsibilities Checking of SOP Compliance. Preparation and Updation of the Site Master File . Preparation and Updation of Validation Master Plan QA SOPs preparation/Revision. Execution of product Disposition/dispatch activity. Tracking of SOP revision due of all departments. Issuance, retrieval and destruction of SOP controlled copies. BMR, BCR issuance, retrieval and review. Line clearance after change over in production areas. Monitoring of routine manufacturing activities. Handling of Change Control. Handling of Deviations. Assist HOD QA for any technical information needed, documents requirement so as to carryout smooth and consistent day-to-day QA activities. Filling customer questionnaire. Feedback giving to marketing related queries. Participate in customer and regulatory audits. Performing vendor/supplier audits. Performing Internal audits. Review of validation & Qualification documents. Preparation of Annual Product Quality Report & updating online trend analysis. Vendor Qualification activity. PR requisition in oracle. Verifying batch no. correctness in oracle before issuance of batch manufacturing records. GMP rounds. Retained documents management. All documents issuance, retrieval and review. Label, Seals procurement, Issuance, Control and Inventory Management. Day-to-day Coordination with all departments. Controlled Copies Issuance related to all departments. Preferred candidate profile Post Graduate in M.Sc with 6 to 8 years or relevant industry experience. Should be able to handle independently. Thorough knowledge of SOP preparation, validation and audits.