Macleods Pharmaceuticals, Walk-In Interview On 2 April 2023 Department: Quality Control/ Production Qualification: B.Sc/ M.Sc/ B.E/ B.Tech/ B.Pharm/ M.Pharm Experience: 2 to 08 years Positions: Officer/ Sr. Officer Location: Sarigam/ Dahej Date : 2nd April 2023 Time: 09:00 AM onwards Venue: VITS Shalimar, Ankleshwar, Valia Road, Near GIDC Reservoir, Ankleshwar, Gujarat

Biophore India Pharmaceuticals Pvt. Ltd. Walk-In Interview On 30 March to 1 April 2023 Department: R&D (Synthesis / Process/ CRO) Qualification: M.Sc (Organic Chemistry) Experience: 01 to 06 years Preferable: Male Candidate’s Skills Required : Good Academic results & Good Communication skills. Freshers also can apply for Trainee Position If you have any queries please reach me On M- 9100033544 /9100033356, recruitments@biophore.com

Sun Pharma- Walk-In Interview On 31-MAR-23 Department: Production Designation: Officer/ Sr. Officer/ Technician Qualification: B.Pharm/ M.Pharm/ ITI/ Diploma Experience: 2 to 6 years Location: Dadra Date: 31st March 2023 Time: 10:00 AM to 04:00 PM Venue: Survey No. 694, Dadra-396193, (U.T of D & N. H.), India

Cipla pharmaceuticals limited Walk-In Interview for Production Department on 31 March 2023 Cipla pharmaceuticals limited Recruitment Details Department: Production Designation: Senior, Executive Qualification: B. Pharmacy, Diploma, B.E, B. Tech Experience: 2-5 Years Interview Details : Date: 31st March 2023 Time: 10:00 AM to 4:00 PM Venue: Hotel Suruchi, Vasudev Balwant Phadke Road, Old Panvel, Navi Mumbai, 410206

Mega Walk-In by Andhra Pradesh State Skill Development Corporation on 31-MAR-23 Andhra Pradesh State Skill Development Corporation (APSSDC), Employment Office and Seedap-Andhra Pradesh Jointly Organizing Mini Job Mela in Nandyala District On 31-March-2023 Participating Companies: Greentech Industries Cygni Energies Pvt. Ltd Aurobindo Date: 31-March-2023 Time: 09:00 AM onwards Venue: ESC Govt. Polytechnic College, Nandyala Interested Candidates can register with Link: https://rb.gy/irtfc1 Note: Candidates must attend in formal dress with copies of resumes and copies of Qualification credentials. For Further Details Please Contact: 9533631002, 8297812530, 6303397635, 9440224291 Or APSSDC Helpline – 9988853335

Job Details... Openings for Quality Assurance (IPQA/ QMS/ Lab QA) Department: Quality Assurance (IPQA/ QMS/ Lab QA) Job Title: Officer / Sr. Officer -Quality Assurance Education Qualification: M.Pharm/ B.Pharm Experience: 02 to 05 years Location: Colvale Goa (Unit II) Incumbent Must Have: Good interpersonal and Communication skills. Experience working in regulated facilities. Good knowledge of cGMP guidelines, QMS, and regulatory Compliance. Hands-on experience with IPQA/ Lab QA/QA QMS. Good Academics, Communication, Analytical and Presentation Skills. Note: Candidates wishing to relocate to Goa can Apply. Kindly mention the subject line as an application for Lab QA/ QMS/ IPQA Share Resume On: Devdas.Gavada@glenmarkpharma.com

Teva Pharmaceuticals Hiring Clinical Research team for Bangalore/ Mumbai location. Interested Candidates may send their CVs at: rekha.chavan@teva.co.in

Nectar Lifesciences Limited, Walk-In Interview for Derabassi Plant on 09-APR-23 at HOTEL WINWAY, 164/1, RNT MARG, INDORE TIME: 09:00 AM TO 05:00 PM.

Update on recent changes in 21 CFR (Code of Federal Regulations) On 02nd March 2023; The text of § 11.100 General requirements of Subpart C Electronic Signatures Title 21 [Food and Drugs] Chapter I [Food and Drug Administration, Department of Health and Human Services] Subchapter A [General] Part 11 [Electronic Records; Electronic Signatures] Subpart C [Electronic Signatures] § 11.100 [General requirements] Comparing the CFR in effect on 02-March-2023 to what was previously in effect on 01-March-2023, Changes are highlighted in the text below. § 11.100 General requirements. (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. (b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. (c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. (1) The certification shall be submitted in paper form and signed with a traditional handwritten signature , to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857 and submitted in electronic or paper form. Information on where to submit the certification can be found on FDA's web page on Letters of Non-Repudiation Agreement. (2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature. Change [62 FR 13464, Mar. 20, 1997, as amended at 88 FR 13018, Mar. 2, 2023]

Shutdown of European Pharmacopoeia 10th Edition The European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023. Consequently, the 10th Edition online and all previous versions, including the Ph. Eur. archives for 10th Edition clients, have no longer been accessible since 31 January 2023. The Ph. Eur. 11th Edition and its supplements are available to subscribers on the dedicated European Pharmacopoeia online platform. Consultation of obsolete Ph. Eur. texts remains possible for users with an up-to-date subscription (i.e. 11th Edition) in the Ph. Eur. archives available on the new platform. Customers who do not yet have access to the Ph. Eur. 11th Edition should verify with their licence manager whether their organisation has purchased a licence. If not, licences can be purchased online at the EDQM store or by contacting orders@edqm.eu. More information is available on the European Pharmacopoeia 11th Edition website.

The ICH Q9(R1) Guideline reached Step 4 of the ICH process on 18 January 2023. The ICH Q9(R1) Quality Risk Management Guideline is intended to provide guidance on the principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality and make limited and specific adjustments to specific chapters and annexes of the current ICH Q9 Guideline on Quality Risk Management (QRM). Further to reaching Step 4 Guideline adoption, the WG continues to work to develop specific training materials (with examples) to supplement the existing ICH briefing pack on ICH Q9, as well as to explain and facilitate the implementation and application of the proposed revisions.

Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format. U.S. Department of Health and Human; Services Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER) have published the draft guideline, This guidance document is being distributed for comment purposes only. Submit Comments by 14th March 2023 Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document, contact (CDER) Eric Brodsky at (301) 796-0855, or (CBER) the Office of Communication, Outreach, and Development at 800-835-4709 or 240-402- 8010. The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.” This guidance is intended to assist applicants in developing the DOSAGE AND ADMINISTRATION section of labeling. The purpose of this guidance is to assist applicants in ensuring that the DOSAGE AND ADMINISTRATION section contains the dosage- and administration-related information needed for safe and effective use of a drug and that the information is clear, concise, and presented in a manner that is pertinent and understandable to health care practitioners. FDA is withdrawing the guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format” issued on March 29, 2010, and issuing this draft guidance. Docket Number: FDA-2007-D-0201 Issued by: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research